MANUFACTURING SPACE AGREEMENT
THIS AGREEMENT made as of January 7, 1999, between Bard
BioPharma L.P., a limited partnership organized and existing under the laws of
the State of Delaware and having its principal place of business at 000
Xxxxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxx 00000 (hereinafter "Bard") and Cytogen
Corporation, a Delaware corporation, having its principal place of business at
000 Xxxxxxx Xxxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx 00000 (hereinafter "Cytogen").
WHEREAS, Cytogen currently manufactures Products and Compounds at the Facility
(each as hereinafter defined); and
WHEREAS, Bard is acquiring a lease to the Facility and certain
of the assets located at the Facility ("Asset Purchase") and is assuming certain
rights and responsibilities with respect to the Facility; and
WHEREAS, in further consideration of the Asset Purchase, Bard
is providing certain space (as hereinafter described) at the Facility to Cytogen
to allow Cytogen to continue the manufacturing of Products and certain Compounds
for third-parties (each as hereinafter defined) and to conduct research
activities, all in accordance with the terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the premises, and for other
good and valuable consideration, the receipt and adequacy of which is hereby
acknowledged by the parties, and intending to be legally bound, the parties
hereby agree as follows:
Article I.
DEFINITIONS
The following terms shall, unless the context otherwise
requires, have the following meanings, respectively:
1.01 "Affiliate" means any corporation or other entity that
controls, is controlled by, or is under common control with a party to this
Agreement. A corporation or other entity shall be regarded as in control of
another corporation or entity if it owns or directly or indirectly controls more
than fifty percent (50%) of the voting stock or other ownership interest of the
other corporation or entity, or has the power to elect or appoint more than
fifty percent (50%) of the members of the governing body of the corporation or
other entity.
1.02 "Asset Purchase" shall have the meaning set forth in the
second Whereas clause of this Agreement.
1.03 "Compounds" shall mean only those compounds manufactured
by Cytogen for third parties that are the subject matter of the third-party
contracts to which Cytogen is a party identified in Schedule A hereto.
1.04 "Confidential Information" means a party's technology,
data, know-how, or information, whether written or oral, technical or
non-technical, including financial statements, reports, pricing, trade secrets,
secret processes, formulas, customer data (including customer lists), and the
like, that relate to the manufacture, packaging, order processing or
distribution of the Product, and that is disclosed to the other party.
1.05 "Cytogen Manufacturing Employee" shall mean each employee
engaged in the manufacture of Compounds and Products at the Facility who is paid
directly by Cytogen and is on Cytogen's payroll and identified on Schedule B
hereof.
1.06 "Direct Labor Costs" means all labor costs, including
without limitation wages, salary, bonuses, benefits and employment taxes, at
Standard Billing Rates, for employees.
1.07 "Direct Costs Other" means all costs for outside testing
and other supplies and materials required for the manufacture, packaging,
testing, and release of the Products and/or the Compounds, as incurred or paid.
1.08 "Effective Date" means the date first shown above.
1.09 "Estimated Annual Workdays" means that number of days
equal to 365, less weekend days, holidays, estimated sick days, training days
and other non-productive days.
2
1.10 "Facility" means the building located at 000 Xxxxxxx
Xxxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx.
1.11 "FDA" means the United States Food and
Drug Administration.
1.12 "Inventory" means all inventories of raw materials, and
work-in-process produced or held by Cytogen in connection with the manufacture
of the Products and the Compounds.
1.13 "Know-How" means the trade secrets, know-how, processes,
formulae, techniques, procedures, test data and other technical information
owned by a party hereto, other than Product Know-How.
1.14 "Manufacturing Space" shall mean the areas of the
Facility labeled as such on Schedule C hereto and made part hereof.
1.15 "Primary Representative" shall have the meaning set
forth in Section 2.07 hereof.
1.16 "Product" or "Products" means ProstaScint and/or
OncoScint, as defined by the FDA labeling thereon and includes the kits and all
associated materials.
1.17 "Product Know-How" means the trade secrets, know-how,
processes, formulae, techniques, procedures, test data and other technical
information, including patented inventions, owned by Cytogen and relating to the
Products and/or the Compounds.
1.18 "Research Space" shall mean the area of the Facility
labeled as such on Schedule D hereto and made part hereof.
1.19 "SOPs" means the written standard operating procedures
and methods utilized by Cytogen in the manufacture of Products or Compounds.
1.20 "Standard Billing Rate" means the daily rate
calculated for each Cytogen Manufacturing Employee and Bard employee and
determined by dividing Total Estimated Annual Compensation by Estimated Annual
Working Days. The Standard Billing Rate may be converted to an hourly rate by
dividing by seven.
3
1.21 "Total Estimated Annual Compensation" means an amount
equal to the aggregate of estimated wages, salary, bonuses, benefits, and
employment taxes of each employee to be paid to or incurred with respect to such
employee during the Estimated Annual Workdays.
Article II.
MANUFACTURING AND RESEARCH USE OF FACILITY
2.01 Use of Facility. (a) Bard hereby grants Cytogen the right
and license to use the Manufacturing Space for the sole purpose of the
manufacture of the Products and the Compounds as heretofore conducted by Cytogen
in the Manufacturing Space at such times and during such periods as shall be
established by the Primary Representatives.
(b) Bard hereby grants Cytogen the right and license to use
the Research Space for the sole purpose of the conduct of Cytogen's research
activities at such times and during such periods as shall be established by the
Primary Representatives.
(c) The right and license to use the Manufacturing Space and
the Research Space granted Cytogen hereby shall include the rights of ingress
and egress to and from the Facility and the use of common areas such as
restrooms as designated by Bard.
(d) Each party agrees to use its reasonable best efforts to
conduct their respective activities and operations at the Facility to the end
that the business activities and operations of a party shall not interfere,
hinder, interrupt or impede the activities and operations of the other party
hereto or impair any requisite compliance by a party hereto with the rules,
regulations or guidelines of the FDA.
2.02 Compliance With Laws. Cytogen shall, at Cytogen's sole
cost and expense, promptly comply with the requirements of all applicable laws,
rules, regulations, statutes, orders and ordinances and all applicable
requirements of any federal, state, county and municipal authorities and/or any
board of fire underwriters or similar organization having jurisdiction over the
Facility, concerning Cytogen's use of the Manufacturing Space and the Research
Space at the Facility and Cytogen's manufacturing and research activities and
operations thereat, including, but not limited to, all requirements of the
4
Occupational Safety and Health Act, and Cytogen shall not make any claim against
Bard for any expenses or damages resulting from such compliance. Cytogen shall
also comply with the New Jersey Industrial Site Recovery Act and all regulations
promulgated thereunder, and shall do all things and execute all documents
necessary for said compliance, including, but not limited to, the submission to
the New Jersey Department of Environmental Protection of all necessary
documentation upon the termination of this Agreement, the termination of
Cytogen's manufacturing and research activities at the Facility or the cessation
of operations by Cytogen at the Facility.
2.03 Vacating the Research and Manufacturing Space. (a)
Cytogen shall use its reasonable best efforts to completely vacate the Research
Space within six (6) months of the date of this Agreement.
(b) In the event that Bard elects to terminate this Agreement
pursuant to Section 7.02 hereof, Cytogen shall immediately cease all activity at
the Facility and then vacate the Facility within thirty (30) days of such
termination.
2.04 Non-Liability. (a) Bard shall not be responsible or
liable to Cytogen for any loss, damage or injury to person or property that may
be occasioned by the acts or omissions of Bard or of any of its employees,
including, but not limited to, any loss, damage or injury resulting to Cytogen
or to any other person or any property of Cytogen or of any other person, from
water, gas, steam, fire or the bursting, stoppage or leakage of sewer or other
pipes, or otherwise resulting from the condition of the Facility, unless same is
due to the gross negligence or willful act of Bard or its employees. In no event
shall Bard be liable for any special, incidental or consequential damages or
loss of profits in the event of any breach by Bard of its obligations hereunder
and Cytogen shall have no rights for any of the foregoing against the partners,
general and limited, of Bard or the right of lien or levy against any property
of Bard (or of any partner, person or entity comprising Bard), nor shall any
property or assets of Bard or such partners be subject to levy, execution or
other enforcement proceedings for the collection of any such sums or
satisfaction of any judgment or award.
(b) Bard shall have no liability to any party with respect to
any Product or Compound approved by Cytogen for shipment or other release from
the Facility.
5
2.06 Insurance. Throughout the term of this Agreement, Bard
shall, at its sole cost and expense, obtain and maintain public liability
insurance and fire and extended coverage on and with respect to the Facility.
Throughout the term of this Agreement, Cytogen shall, at its sole cost and
expense, obtain and maintain in full force and effect product liability
insurance (issued by an insurance company licensed to do business in New Jersey
and reasonably acceptable to Bard) covering the Facility, the Products, the
Compounds and all operations of Cytogen, in the amount of Ten Million Dollars
($10,000,000.00), which insurance shall name Bard as an additional insured
thereunder. Cytogen shall, at all times during the term of this Agreement,
maintain in full force and effect and on deposit at Bard's office, a Certificate
of Insurance or a duplicate original of the insurance policy required above,
together with evidence of payment of all premiums therefor. Any such policy
shall provide that it shall not be cancelable without at least thirty (30) days
prior written notice to Bard. If Cytogen shall default in maintaining such
product liability insurance, Bard may, at its option and without waiving any of
its rights hereunder or releasing Cytogen from any obligation hereunder, procure
such insurance, and Cytogen shall, on demand, reimburse Bard for the cost
thereof.
2.07 Primary Representatives. Each party shall appoint a
primary representative ("Primary Representative") who shall coordinate the
operations and activities of the parties at the Facility. The Primary
Representatives shall be responsible for the day-to-day contacts between the
parties hereto and shall receive copies of all written correspondence exchanged
between the parties with respect to any necessary coordination of operations and
activities at the Facility. If a Primary Representative leaves the employ of a
party, an equally competent, mutually acceptable, Primary Representative shall
be assigned by such party.
2.08 Regulatory Responsibility. Cytogen shall be solely
responsible and liable for the management and control and all regulatory aspects
of the manufacturing operations, equipment and employees engaged in
manufacturing activities at the Manufacturing Space; provided, however, that
Bard shall use its reasonable best efforts to maintain the Facility and
6
associated utilities in compliance with applicable local, state and federal
requirement, including current FDA Good Manufacturing Practices.
Article III.
EMPLOYEES
3.01 Employees Engaged in Manufacturing. All employees engaged
in the manufacture of Products and Compounds at the Manufacturing Space and
activities and operations ancillary to or undertaken in connection with the
manufacture of Products and Compounds shall be under the exclusive management,
direction and control of Cytogen at all times during which such employees are so
engaged. Cytogen shall maintain an employee at all times with responsibility for
quality assurance of Products and Compounds, and no Product or Compound shall be
shipped or otherwise released from the Facility unless such employee has
approved its shipment or release in writing.
3.02 Reimbursement of Costs -- Cytogen.
(a) Cytogen shall be responsible for paying all Direct Labor
Costs of Cytogen Manufacturing Employees and the Direct Costs Other of Cytogen's
manufacturing operations and activities.
(b) The Cytogen Primary Representative will provide the Bard
Primary Representative on the first day of each month with a written schedule
identifying the Cytogen Manufacturing Employees and estimating the time such
employees will be engaged in the manufacture of Products and Compounds at the
Manufacturing Space for the next succeeding month, such schedule to be in the
formats provided for in clauses (i), (ii) and (iii) below. The time in such
month in which Cytogen Manufacturing Employees are engaged in the manufacture of
Products and/or Compounds is hereafter referred to as "Cytogen Worktime."
(i) With respect to Cytogen Manufacturing Employees
directly engaged in the manufacture of Products and Compounds ("Direct
Manufacturing Employees") Cytogen shall prepare a schedule identifying
the number of full work days in such month that each such employee will
be engaged in the manufacture of Products and Compounds. For purposes
of this Section 3.02(b)(i), a Direct Manufacturing Employee engaged in
7
the manufacture of products and compounds for four (4) hours or more in
a day shall constitute a full work day for such employee.
(ii) With respect to Cytogen Manufacturing Employees
having supervisory responsibility ("Supervisory Employees") for the
manufacture of Products and/or Compounds, Cytogen will prepare a
schedule reflecting the number of hours in such month that each such
employee will be engaged in the supervision of the manufacture of
Products and/or Compounds.
(iii) With respect to Cytogen Manufacturing Employees
having responsibility for validation, material handling, equipment
maintenance and purchasing ("General Duty Employees"), Cytogen shall
prepare a schedule reflecting the numbers of hours in such month that
each such employee's activities will be undertaken in connection with
Cytogen's manufacturing operations and activities. The parties
anticipate that General Duty Employees will be employed by Bard in
approximately six (6) to nine(9) months.
(c) Cytogen will xxxx Xxxx on the first day of each month an
estimated amount equal to the aggregate of the sums determined in accordance
with clause (i), (ii), (iii) below.
(i) (A) Direct Labor Costs incurred or spent by Cytogen
in respect of Direct Manufacturing Employees for such month minus (B)
an amount equal to the product of 1.5 multiplied by the Cytogen
Worktime of such employees for the prior month (excluding the first
month of this Agreement) multiplied by Standard Billing Rates on a
daily or hourly basis, as applicable.
(ii) (A) Direct Labor Costs incurred or spent by
Cytogen in respect of Supervisory Employee minus (B) an amount equal to
the product of 1.5 multiplied by the Cytogen Worktime of such employees
for the prior month (excluding the first month of this Agreement) month
multiplied by Standard Billing Rates on an hourly basis.
8
(iii) (A) Direct Labor Costs incurred by or spent by
Cytogen in respect of General Duty Employees for such month minus (B)
an amount equal to the product of .75 multiplied by the Cytogen
Worktime of such employees for the prior month (excluding the first
month of this Agreement) multiplied by Standard Billing Rates on an
hourly basis.
(d) Bard shall reimburse Cytogen in respect of the
establishment fee payable in respect of the Facility to permit the manufacture
of Products and Compounds in the Facility as follows: an amount equal to 70% of
the amount paid by CYTOGEN in respect of such establishment fee in the first
year of this agreement; an amount equal to 80% of the amount paid by Cytogen in
respect of such establishment fee in the second year of this agreement, and an
amount equal to 85% of the amount paid by CYTOGEN in respect of such
establishment fee in the third year of this agreement.
(e) Amounts due Cytogen will be paid by wire transfer
within three (3) business days from the date of receipt of a billing.
(f) Cytogen will summarize all of its Direct Labor Costs and
Direct Costs Other incurred or spent on its manufacturing operations at the
Facility at the end of each month in sufficient detail and with supporting
documentation as agreed from time-to-time by the parties. Supporting
documentation in respect of Supervisory Employees and General Duty Employees
shall be by means of time records and maintained by such employees reflecting on
an hourly basis the time spent each day by such employees in manufacturing
activities and non-manufacturing activities separately stated.
(g) Any overpayments or underpayments pursuant to an estimated
billing shall be adjusted by the parties and appropriate payments made to the
other party within five (5) business days after the determination thereof.
3.03 Employee Liabilities. Bard and Cytogen shall be wholly
responsible for the following with respect to their respective employees:
short-term disability, long-term disability, workers' compensation, personal
injury liability, severance payments and all other costs and expenses part of
Direct Labor Costs.
9
Article IV.
PAYMENTS
4.01 Payments to Bard. In consideration for Bard's agreement
to perform its obligations hereunder and for the right to use and access to the
Manufacturing Space, Cytogen covenants and agrees to pay to Bard for the
manufacturing access rights granted hereby, without demand or notice, and
without any set-off or deduction and regardless of Cytogen's use or non-use of
the Manufacturing Space, as follows:
(a) For the period commencing on the date hereof and ending on
the date that is one year from the date hereof (the "First Anniversary Date"),
the sum of Four Hundred Thousand Dollars ($400,000.00) per annum, payable in
quarterly installments of One Hundred Thousand Dollars ($100,000);
(b) For the period commencing on the day after the First
Anniversary Date and ending on the date that is two (2) years from the date
hereof (the "Second Anniversary Date"), the sum of Six Hundred Thousand Dollars
($600,000.00) per annum, payable in quarterly installments of One Hundred Fifty
Thousand Dollars ($150,000.00); and
(c) For the period commencing on the day after the Second
Anniversary Date and ending on the date that is three (3) years from the date
hereof, the sum of Eight Hundred Thousand Dollars ($800,000.00) per annum,
payable in quarterly installments of Two Hundred Thousand Dollars ($200,000).
4.02 Labor and Other Costs. In the event Cytogen utilizes the
services of individuals employed by Bard, Bard will xxxx Cytogen and Cytogen
will pay to Bard within ten (10) business days of such billing one hundred fifty
percent (150%) of the Standard Billing Rates for all Direct Labor Costs of such
individuals, plus one hundred fifty percent (150%) of all Direct Costs Other
incurred by Bard in rendering such assistance on a monthly basis; provided,
however, that employees previously employed as General Duty Employees shall be
billed at seventy five percent (75%) of the Standard Billing Rate.
4.03 Research Space Rent. Cytogen will pay to Bard the greater
of $4,000 per month in each of the first six months from the date hereof for the
10
rights granted hereunder with respect to the Research Space, such payment to
terminate upon Cytogen's complete vacating of the Research Space. In the event
that Cytogen fails to completely vacate the Research Space within six (6) months
of the date of this Agreement, Cytogen will pay Bard $10,000 per month for each
succeeding month after the conclusion of the initial six (6) month period until
such time as Cytogen has completely vacated the Research Space.
4.04 Due Date. Unless otherwise provided, all payments
required under this Article IV shall be made, without demand or notice, on or
before the last day of each calendar quarter. Notwithstanding anything to the
contrary herein, if the date of this Agreement occurs on a day other than the
first day of the calendar month, all payments hereunder for such partial
calendar month shall be prorated and paid on the date provided for in this
Section 4.04.
4.05 Deemed Accrual. Cytogen's obligation to make all the
payments required under Sections 4.01(a), (b) and (c) hereof shall be deemed to
have accrued as of the date hereof and shall survive any early termination of
this Agreement, except any such early termination resulting from willful
misconduct by Bard constituting a breach or default hereunder by Bard.
Article V.
SECURITY INTEREST IN COLLATERAL
5.01 Security Interest. In order to secure the payment and
performance by Cytogen of all of its obligations and liabilities under this
Agreement, and in consideration of Bard's agreement to undertake its obligations
hereunder, and intending to be legally bound hereby, Cytogen hereby grants to
Bard a security interest in the following property of Cytogen and any Affiliate
of Cytogen: the Inventory (wherever located) and raw materials and equipment and
other Cytogen tangible assets used in connection with Cytogen's manufacturing
activities or otherwise (collectively the "Collateral"). This Agreement creates
such security interest in the Collateral and constitutes a security agreement
under the New Jersey Uniform Commercial Code. Cytogen shall execute, file and
11
re-file such financing statements and other such security agreements as Bard
shall require from time to time with respect to the Collateral. Cytogen hereby
authorizes Bard to file such financing statement or statements pursuant to the
Uniform Commercial Code, without the signature of Cytogen, as Bard may deem
necessary to perfect such security interest or rights in its favor.
Article VI.
RECORDS, AUDITS, INSPECTIONS,
RECALLS AND RETURNS
6.01 Records and Accounting by Cytogen. Cytogen shall keep
complete and accurate records of the manufacture, testing and shipping of the
Products and the Compounds as required by law, including all of the foregoing
required under the rules, regulations or guidelines of the FDA.
6.02 Regulatory Inspections. Cytogen will inform Bard promptly
and, if possible, in advance, of any inspection or audit by any governmental
agency, including the FDA, related to the Products, the Compounds or the
Manufacturing Space and will inform Bard of the result of any such audit or
inspection within twenty-four (24) hours of the conclusion of such audit or
inspection. Cytogen will promptly provide Bard with copies of any
government-issued inspection observation reports and related correspondence,
that affect the Products, the Compounds or the Manufacturing Space. Cytogen will
diligently pursue the resolution of all concerns expressed by the FDA or other
governmental agency. Bard hereby agrees that it will permit authorized
representatives of the FDA to inspect the Manufacturing Space. In the event that
the FDA performs an inspection of Bard's utilization of the Facility and the
results of such inspection would impair Cytogen's manufacturing operations and
activities, Bard and Cytogen will cooperate in resolving the concerns of the FDA
to the end that Cytogen's manufacturing operations and activities may continue
to be performed in the Manufacturing Space.
6.03 Inspections. The Primary Representative of Cytogen will
have access during audits to all employee-related documents, records, reports,
data, procedures, facilities, and all other information required to be
maintained by FDA regulations or the requirements of other governmental
agencies.
6.04 Safety and Complaint Reporting. Cytogen agrees to comply
with all obligations concerning the collection, investigation, and governmental
reporting of adverse reactions and complaints relating to the Products and the
12
Compounds, including, without limitation, all obligations under 21 CFR 312.32
and 21 CFR 314.80(a).
6.05 Recall Action. Only Cytogen may initiate a recall action
of the Product or Compounds. Cytogen shall inform Bard if Cytogen determines it
is necessary to initiate a recall, withdrawal or field correction. All FDA
contacts and coordination of any recall activities will be handled solely by
Cytogen.
6.06 Recall Expenses. Cytogen will be responsible for any and
all costs associated with a recall, withdrawal or field correction for any
reason except to the extent that such a recall is due to the willful misconduct
of Bard.
6.07 Product Returns. Cytogen will have the responsibility for handling all
customer returns of the Products or --------------- Compounds.
6.08 Waste. In its performance of this Agreement, Cytogen and
Bard shall comply with all laws and regulations applicable to the generation,
storage, shipment and disposal of waste generated in the manufacture of the
Products and the Compounds.
6.09 Biohazards. The Primary Representatives will establish a
standard operating procedure to identify materials to be brought into the
Facility that are or may be biohazardous. Materials so identified shall not be
brought into the Facility.
6.10 Product Safety. Cytogen represents and warrants to Bard
that the safety profile of the Products is as described in the package inserts
thereto and to the best of Cytogen's knowledge Cytogen has no knowledge of any
adverse event or experience with the Products that is not referenced or
described in the package insert.
Article VII.
TERM, RENEWAL AND TERMINATION
7.01 Term. Except with respect to the Research Space and
unless earlier terminated in accordance with this Article VII, this Agreement
will be in effect and will continue for a period of three (3) years from the
Effective Date.
13
7.02 Default; Breach. Either Cytogen or Bard may terminate
this Agreement at any time on written notice if the other party breaches or
defaults under a material term of this Agreement and fails to remedy the breach
or default within sixty (60) days after receiving written notice of the breach
or default. The breach or default of a payment obligation hereunder shall be
deemed material, and, notwithstanding the sixty (60) day period to cure
previously provided, must be cured within two (2) days of the receipt of written
notice of such default.
7.03 Insolvency. Bard or Cytogen may terminate this Agreement
in its entirety if Cytogen (in the case of termination by Bard) or Bard (in the
case of termination by Cytogen) files a petition of bankruptcy, is adjudged
bankrupt, takes advantage of any insolvency act, or executes a xxxx of sale,
deed of trust, or assignment for the benefit of creditors.
7.04 Survival. The rights and obligations contained in the
sections hereof providing for indemnification and confidentiality will survive
the termination of this Agreement, as will any rights to payment or other rights
or obligations that have accrued under this Agreement prior to termination. The
termination of this Agreement will not affect a party's liability as provided
for herein by reason of any act, default, or occurrence prior to such
termination or, unless such termination results from willful misconduct by Bard
constituting a breach or default hereunder by Bard, Cytogen's obligation to make
the payments provided for in Section 4.01(a), (b) and (c) hereof.
Article VIII.
INDEMNITY
8.01 (a) Indemnification By Cytogen. Cytogen shall indemnify
and hold harmless Bard, its officers, directors, partners, attorneys, agents,
and employees, and their successors and assigns, from and against any and all
losses, suits, liabilities, damages, claims, injuries, costs and expenses,
including reasonable attorneys' fees and expenses of litigation (collectively
"Claims"), resulting from, arising out of or in any manner incident, relating or
attributable to: (i) the negligence or willful misconduct of Cytogen; (ii) the
material breach by Cytogen of any term or provision of this Agreement; (iii) any
failure by Cytogen or its Affiliates to perform or observe, in full, any
14
covenant, agreement or condition to be performed or observed by them in this
Agreement; (iv) the termination by Cytogen of its third-party manufacturing
agreements and all activities conducted thereunder; (v) the termination of
employment of any former employees of Cytogen at the Facility; (vi) the use,
operation and occupancy of the Manufacturing Space and Research Space; and/or
(vii) Products or Compounds shipped from or otherwise released from the
Facility.
(b) Indemnification By Bard. Subject to the provisions of
Section 2.04, Bard shall indemnify and hold harmless Cytogen, its officers,
directors, partners, attorneys, agents, and employees, and their successors and
assigns, from and against any and all Claims that result from (i) the gross
negligence or willful misconduct of Bard; (ii) the material breach by Bard of
any term or provision of this Agreements and/or (iii) an act by Bard for which
Bard would be liable to Cytogen hereunder.
8.02 Indemnification Procedures. Each indemnified party agrees
to give the indemnifying party prompt written notice of any Claim or discovery
of fact upon which such indemnified party intends to base a request for
indemnification under Section 8.01. Each party shall furnish promptly to the
other copies of all papers and documents received in respect of any Claim. With
respect to any Claim relating solely to the payment of money damages that will
not result in the indemnified party becoming subject to injunctive or other
relief or otherwise adversely affecting the business of the indemnified party in
any manner, and as to which the indemnifying party shall have acknowledged in
writing the obligation to indemnify the indemnified party hereunder, the
indemnifying party shall have the sole right to defend, settle or otherwise
dispose of such Claim upon such terms as the indemnifying party, in its sole
discretion, shall deem appropriate. The indemnifying party shall obtain the
written consent of the indemnified party, which shall not be unreasonably
withheld, prior to ceasing to defend, settling or otherwise disposing of any
Claim if, as a result thereof, the indemnified party would become subject to
injunctive or other equitable relief or any remedy other than the payment of
money, which payment would be the responsibility of the indemnifying party. The
indemnifying party shall not be liable for any settlement or other disposition
of a Claim by the indemnified party which is made without the consent of the
indemnifying party. Except as provided above, the reasonable costs and expenses,
15
including reasonable fees and disbursements of counsel incurred by any
indemnified party in connection with any Claim shall be reimbursed on a
quarterly basis by the indemnifying party, without prejudice to the indemnifying
party's right to contest the indemnified party's right to indemnification and
subject to refund in the event that the indemnifying party is ultimately held
not to be obligated to indemnify the indemnified party.
Article IX.
CONFIDENTIALITY
9.01 Disclosure Promptly after the Effective Date. Each party
will provide to the other party any and all Confidential Information that is
necessary for such party to perform its obligations hereunder.
9.02 Restrictions on Disclosure and Use by Both Parties. No
party will use the Confidential Information provided by the other party or
disclose it to any third party except as necessary to carry out the party's
obligations under this Agreement. If either party finds it necessary to disclose
such Confidential Information to a third party, they will not do so without
first obtaining the written consent of the other party and entering into an
agreement with the third party that binds the third party to the same
obligations of restricted use and disclosure as are undertaken by the parties in
this Agreement. This Section 9.02 shall survive the termination of this
Agreement.
9.03 Exceptions. The obligations under Section 9.02 will not
apply to any information that (a) is in the possession of the receiving party at
the time of receipt from the disclosing party, as shown by existing records, (b)
is or becomes available to the public through no fault of the receiving party,
(c) is disclosed to the receiving party by a third party entitled to disclose
it, (d) is independently developed by the receiving party without reliance on
information supplied by the disclosing party, as evidenced by the records of the
receiving party, or (e) is required by law or judicial order to be disclosed, in
which case the party required to make the disclosure shall (i) provide as much
advance notice as possible to the disclosing party, (ii) to the extent possible,
allow the disclosing party to seek a protective order, and (iii) to the extent
possible, minimize the information to be disclosed.
16
Article X.
THIRD-PARTY MANUFACTURING
10.01 Termination of Third-Party Manufacturing at the
Facility. Cytogen shall use its reasonable best efforts to cease work in the
Facility with respect to manufacturing not later than December 31, 1999.
10.02 Biomira Agreement. Cytogen represents and warrants to
and with Bard that (i) that certain agreement dated June 4, 1997 between Cytogen
and Biomira (USA), Inc. ("Biomira") has terminated, (ii) that Cytogen has no
obligation thereunder or otherwise to Biomira which would require use of the
Facility and (iii) that in connection with Cytogen's performance of the
aforesaid agreement, no biohazardous materials were permitted to enter the
Facility.
10.03 Completion of Manufacturing Obligations. Cytogen shall
be solely responsible to perform the manufacturing services for third parties
that may be required following the Effective Date pursuant to the third-party
manufacturing agreements identified on Schedule A attached. No third-party
contract manufacturing shall be undertaken by Cytogen at the Facility except in
respect of Cytogen's performance of the agreements identified on Schedule A
attached. Cytogen covenants, represents, warrants to and with Bard that Schedule
A sets forth a true, accurate and complete list of all third-party manufacturing
agreements, copies of which have been delivered by Cytogen to Bard, and there
are no other agreements or arrangements regarding such third-party
manufacturing. Cytogen covenants, represents, warrants and agrees that no
biohazardous materials were permitted to enter the Facility in connection with
such third-party manufacturing.
10.04 Biohazardous Materials-Definition. For purposes of this
Article X, "biohazardous materials" means microbiological or viral agents of
infection, including but not limited to bacteria, fungae, mycoplasmas, prions
and viruses which are considered to be pathogenic or harmful to human health.
17
Article Xl.
MISCELLANEOUS
11.01 Compliance with Laws. Each party, in connection with its
performance under this Agreement, shall comply with all applicable laws, rules,
regulations, orders and guidelines.
11.02 Trademarks. Each party hereby acknowledges that no such
party has, nor shall it acquire, any interest in any of the other party's
trademarks or trade names unless otherwise expressly agreed to herein or in
writing. The parties agree not to use any trademark or trade name of the other
party, except as specifically authorized by the other party.
11.03 Independent Contractors. The parties are independent
contractors, and this Agreement shall not be construed to create between Bard
and Cytogen any other relationship such as, by way of example only, that of
employer-employee, principal-agent, joint-venturer, co-partners or any similar
relationship, the existence of which is expressly denied by the parties hereto.
11.04 No Waiver. A party's failure to require another party to
comply with any provision of this Agreement shall not be deemed a waiver of such
provision or any other provision of this Agreement.
11.05 Assignment. No party may assign this Agreement or any of
its rights or obligations hereunder except with the prior written consent of the
other parties, except that either party may assign its rights and obligations
under this Agreement to an Affiliate; provided, however, that any such
assignment to an Affiliate shall not relieve the assigning party of its rights
and obligations hereunder.
11.06 Force Majeure. No party shall be liable for the failure
to perform its obligations under this Agreement if such failure is occasioned by
a contingency beyond such party's reasonable control, including, but not limited
to, strikes or other labor disturbances, lockouts, riots, wars, fires, floods or
storms. A party claiming a right to excuse performance under this Section 11.06
shall immediately notify the other party in writing of the extent of its
inability to perform, which notice shall specify the occurrence beyond its
18
reasonable control that prevents such performance and an estimate of the time
that the inability to perform is anticipated to last.
11.07 Notices. Any notice, approval, instruction or other
written communication required or permitted hereunder shall be sufficient if
made or given to the other party by personal delivery, by overnight delivery
service, or by sending the same by first-class mail, postage prepaid to the
address set forth below:
If to Bard:
Bard BioPharma L.P.
000 Xxxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx
with a copy to:
Xxxxxx X. Xxxxx, Esq.
Xxxxxxx, Xxxxxx & Xxxxx
000 Xxxxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
If to Cytogen:
Xxxxxxx Xxxxxxxxxxx
000 Xxxxxxx Xxxx Xxxx - XX 0000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: H. Xxxxxx Xxxxxx, Ph.D.
Either party may notify the other party from time to time of
any change of address for notices required by this Agreement. Notices hereunder
shall be deemed to have been sufficiently made or given when received.
11.08 Third Parties. No person not a party to this Agreement
or an Affiliate of a party to this Agreement (including without limitation any
present or former employee of Cytogen and the third-parties to the third-party
contracts listed on Schedule A hereto) shall have or acquire any rights by
reason of this Agreement, nor shall any party to this Agreement have any
obligation or liabilities to such other person by reason of this Agreement.
11.09 Entire Agreement. This Agreement constitutes the full,
complete, final and integrated Agreement between the parties hereto relating to
the subject matter hereof and supersedes all previous written or oral
19
negotiations, commitments, agreements, transactions or understandings with
respect to the subject matter hereof. Any modification, amendment or supplement
to this Agreement must be in writing and signed by authorized representatives of
both parties.
11.10 Headings. The titles and headings herein are for
convenience only and shall not be used to interpret or construe the terms and
conditions of this Agreement.
11.11 Interpretation. The parties hereto acknowledge and agree
that: (i) each party and its counsel have reviewed and negotiated the terms and
provisions of this Agreement and have contributed to its revision; (i) the rule
of construction to the effect that any ambiguities are resolved against the
drafting party shall not be employed in the interpretation of this Agreement;
and (iii) the terms and provisions of this Agreement shall be construed fairly
as to all parties hereto and not in favor of or against any party, regardless of
which party was generally responsible for the preparation of this Agreement.
11.12 Specific Performance. Bard and Cytogen agree that if a
limitation of liability provided for herein would make money damages an
inadequate remedy in respect of a breach, threatened breach or failure to
perform under this Agreement to the non-breaching party, the non-breaching party
shall be entitled to injunctive or equitable relief and a decree for specific
performance. Nothing in this Section 11.12 shall in any manner constitute a
waiver of or limit any limitation of liability otherwise provided for herein.
11.13 Singular Terms. Except as otherwise expressly provided
herein or unless the context otherwise requires, all references to the singular
shall include the plural as well.
11.14 Execution in Counterparts. This Agreement may be
executed in one or more counterparts, each of which shall be deemed an original,
but all of which together shall constitute one and the same instrument.
11.15 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the
00
Xxxxx xx Xxx Xxxxxx, without reference to its conflicts of law
provisions, and the United States of America.
IN WITNESS WHEREOF, the duly authorized representatives of the
parties have executed this Agreement as of the dates set forth below.
BARD BIOPHARMA L.P.
By Bard Pharmaceuticals Inc.,
as General Partner
By:/s/ Xxxxxx X.
Name: Xxxxxx X. Xxxxxx
Title: Vice President
Date: January 7, 1999
CYTOGEN CORPORATION
By:/s/ H. Xxxxxx Xxxxxx
Name: H. Xxxxxx Xxxxxx
Title: CEO
Date: January 7, 1999
21
SCHEDULE A
CYTOGEN THIRD-PARTY CONTRACTS
AGREEMENT dated as of August 30, 1996 by and between XXXXXXX PHARMACEUTICAL INC.
and CYTOGEN Corporation.
AGREEMENT dated as of January 24, 1997 by and between PROGENICS PHARMACEUTICALS
INC. and CYTOGEN Corporation.
AGREEMENT dated as of February 25, 1998 by and between EMISPHERE TECHNOLOGIES,
INC. and CYTOGEN Corporation.
AGREEMENT dated as of May 15, 1997 by and between AMERICAN BIOGENETIC SCIENCES,
INC. and CYTOGEN Corporation.
AGREEMENT dated as of June 4, 1997 by and between DELTA PHARMACEUTICALS, INC.
and CYTOGEN Corporation.
AGREEMENT dated as of August 13, 1997 by and between MEDAREX, INC. and CYTOGEN
Corporation.
AGREEMENT dated as of July 29, 1997 by and between LEUKOSITE INC. and CYTOGEN
Corporation.
Fill obligation to Centocor, the contract terms with respect to which are
being finalized.
22
SCHEDULE B
CYTOGEN MANUFACTURING EMPLOYEES
Direct Manufacturing Supervisory General Duty
Employees Employees Employees
-------------------- ----------- ----------
Xxxxxx Xxxxxxxxx Xxxxxx
Gojaniak Ultee Hazard
Xxx Xxxxxxx Xxxx Xxxxxxx
Xxxxxx Xxxxx Xxxxxx
Xxxxxx Xxxxx Xxxxxxx
Xxxxx Pienciak
Lacotera Balla
Xxxxxx Xxxxx
Frisbee Peacos
Freemen Xxxxxxx
Xxxxxxxx Loss
Xxxx Xxxxxxxxxx
Xxxxxx Aiken
Stratowski
23
SCHEDULE C
MANUFACTURING SPACE
Map of Manufacturing Space.
24
SCHEDULE D
RESEARCH SPACE
Map of Research Space.
25
