Drug Product Development and Clinical Supply Agreement
Exhibit
10.1
Form
8-K
Bio-Path
Holdings, Inc.
File No.
000-53404
THIS AGREEMENT is effective as
of the 24th day of
June, 2008 (“Effective Date”).
BY
AND BETWEEN:
Bio-Path
Holdings, Inc., a corporation organized and existing under the laws of the State
of Utah, with its principal offices located at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to
as “CLIENT”).
AND:
▇▇▇▇▇▇ TECHNOLOGIES, INC., a
Delaware corporation, with a place of business located at ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to as “▇▇▇▇▇▇”);
WHEREAS CLIENT has
formulations and/or know-how related to each Drug Product, as defined
below;
WHEREAS ▇▇▇▇▇▇ has the
expertise and the manufacturing facility suitable for the Production of Drug
Product;
WHEREAS, CLIENT wishes to have
▇▇▇▇▇▇ Produce Drug Product and ▇▇▇▇▇▇ wishes to Produce Drug Product for
CLIENT;
NOW, THEREFORE, in
consideration of the premises and the undertakings, terms, conditions and
covenants set forth below, the parties hereto agree as follows:
Article
1, DEFINITIONS.
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1.1
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AFFILIATE of a party
hereto shall mean any entity that controls or is controlled by such party,
or is under common control with such party. For purposes of
this definition, an entity shall be deemed to control another entity if it
owns or controls, directly or indirectly, at least fifty percent (50%) of
the voting equity of another entity (or other comparable interest for an
entity other than a corporation).
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1.2
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▇▇▇▇▇▇ SOPs shall mean
ALTHEA’S Standard Operating Procedures which shall be deemed reviewed and
approved by CLIENT unless prior to manufacture of CLIENT’s Drug Product
CLIENT’s representative audits ALTHEA’s SOPS and has modifications deemed
necessary for the manufacture of CLIENT’s Drug
Product.
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1.3
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BATCH shall mean a
specific quantity of a Drug Product comprising a number of units mutually
agreed upon between CLIENT and ▇▇▇▇▇▇, and that (a) is intended to have
uniform character and quality within specified limits, and (b) is produced
according to a single manufacturing order during the same cycle of
manufacture.
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1.4
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BULK DRUG SUBSTANCE
shall mean the active compound, as set forth in the Project Plan,
to be supplied by CLIENT for use in Production of Drug
Product.
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1.5
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cGMP shall mean current
Good Manufacturing Practices as defined in the FDA rules and regulations,
21 CFR Parts 210-211.
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1.6
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CANCELLATION FEES shall
mean the fees payable by CLIENT in the event that CLIENT cancels the
Production of any Batch of Drug Product set forth in the Project Plan,
except in the event of a default by ▇▇▇▇▇▇ as set forth in Section
3.3.
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1.7
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COMPONENTS shall mean
all Components used by ▇▇▇▇▇▇ in Production of Drug Product under this
Agreement. Components are listed in the Project Plan,
such Components identified as Components supplied by CLIENT (“CLIENT
Supplied Components”) and Components supplied by ▇▇▇▇▇▇ (“▇▇▇▇▇▇ Supplied
Components”).
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1.8
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CONFIDENTIAL INFORMATION
shall mean all information and data provided by one party to the other
party except any portion of such information and data
which:
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(i)
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is
known to the recipient as evidenced by its written records before receipt
thereof from the disclosing party;
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(ii)
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is
disclosed to the recipient by a third person who has the right to make
such disclosure;
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(iii)
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is
or becomes part of the public domain through no fault of the recipient;
or
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(iv)
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the
recipient can reasonably establish has been independently developed by
recipient without use of the information disclosed by the disclosing
party.
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1.9
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DEVELOPMENT shall mean
studies conducted by ▇▇▇▇▇▇ to develop a process to Produce Drug Product,
in accordance with the Specifications and cGMP. Development
activities shall be identified in the Project
Plan.
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1.10
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DRUG PRODUCT shall mean
each pharmaceutical product set forth in a development & regulatory
Plan, if applicable, and a Project Plan to be Produced by ▇▇▇▇▇▇ in bulk
or finished dosage form for development and/or clinical use
only.
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1.11
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FDA shall mean the
United States Food and Drug Administration or any successor entity
thereto.
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1.12
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FD&C ACT shall mean
the United States Federal Food, Drug and Cosmetic Act, as may be amended
from time to time.
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1.13
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IND shall mean an
Investigational New Drug Application for Drug Product, as defined in the
United States Food and Drug Administration (FDA) rules and regulations, 21
CFR.
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1.14
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LABELING shall mean all
labels and other written, printed, or graphic matter upon: (i) Drug
Product or any container, carton, or wrapper utilized with Drug Product or
(ii) any written material accompanying Drug
Product.
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1.15
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MASTER BATCH RECORD (MBR)
shall mean the formal set of instructions for Production of Drug
Product. The MBR shall be developed and maintained in ALTHEA’s
standard format by ▇▇▇▇▇▇, using CLIENT’s master formula and technical
support.
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1.16
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PRODUCTION or PRODUCE
shall mean the formulation, filling, packaging, inspection,
labeling, and testing of Drug Product by
▇▇▇▇▇▇.
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1.17
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PRODUCT SPECIFICATION
SHEET shall mean a listing of the analytical testing and
corresponding Specifications, to be performed on the Bulk Drug Substance
and Drug Product in connection with the stability
program.
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1.18
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PROJECT PLAN shall mean
the document containing the parameters for Production of Drug Product
which shall be developed by ▇▇▇▇▇▇ and agreed to in writing by CLIENT for
each Drug Product under this Agreement. Prior to commencing
Production of any Drug Product, ▇▇▇▇▇▇ shall deliver two (2) signed
originals of the Project Plan to CLIENT. CLIENT shall sign both
originals of the Project Plan and return one (1) fully executed original
to ▇▇▇▇▇▇. Each fully executed Project Plan shall be
incorporated herein by reference and made a part of this
Agreement. ▇▇▇▇▇▇ shall have no obligation for Production of a
Drug Product until CLIENT has executed and returned the Project Plan for
such Drug Product to ▇▇▇▇▇▇.
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1.19
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PURCHASE PRICE shall
mean the amount to be paid by CLIENT as specified in each Project
Plan.
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1.20
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REGULATORY AUTHORITY
shall mean those agencies or authorities responsible for regulation
of Drug Product in the United States and overseas. ▇▇▇▇▇▇ shall
have no obligation to Produce Drug Product in compliance with the
requirements of a Regulatory Authority not specified in the applicable
Project Plan.
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1.21
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RELEASED EXECUTED BATCH
RECORD shall mean the completed batch record and associated
deviation reports, investigation reports, and Certificates of Analysis
created for each Batch of Drug
Product.
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1.22
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SPECIFICATIONS shall
mean those specifications set forth in Product Specification Sheet and the
Master Batch Record for Drug Product, and to the extent that ▇▇▇▇▇▇ is
required to test the Bulk Drug Substance, for the Bulk Drug
Substance.
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Article
2, DEVELOPMENT AND PRODUCTION OF DRUG PRODUCT.
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2.1
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Initiation: Upon
execution of this Agreement and the corresponding Project Plan for each
Drug Product, ▇▇▇▇▇▇ shall commence Development of such Drug Product
pursuant to the timeline set forth in the Project Plan. Upon
execution of this Agreement and the corresponding Project Plan for each
Drug Product, ▇▇▇▇▇▇ shall commence Production of such Drug Product
pursuant to the Project Plan. ▇▇▇▇▇▇ shall diligently perform
the work necessary to complete the Development and Production of such Drug
Product in accordance with the Project
Plan.
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2.2
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Documentation: The
Master Batch Record shall be reviewed and approved by ▇▇▇▇▇▇ and by CLIENT
prior to commencement of Production. Any material change to an
approved Master Batch Record will be reviewed and approved by ▇▇▇▇▇▇ and
by CLIENT prior to said change being implemented. Each Batch of
Drug Product shall be Produced by using a copy of the Master Batch
Record. Each copy of the Master Batch Record for such Batch of
Drug Product shall be assigned a unique batch number. Any
deviation from the manufacturing process specified in the Master Batch
Record must be documented in the copy of the Master Batch Record for that
Batch. ▇▇▇▇▇▇ shall provide CLIENT with required supporting
Development and Production documentation in a form reasonably suitable for
CLIENT's submission to the FDA.
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2.3
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Bulk Drug Substance and
Components Supply:
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2.3.1 CLIENT
Responsibilities: CLIENT, at its sole cost and expense (including,
without limitation, shipping costs), shall supply to ▇▇▇▇▇▇, in a timely
manner, (a) all Bulk Drug Substance required to satisfy the terms of this
Agreement and (b) all other CLIENT Supplied Components, all to be
delivered to ▇▇▇▇▇▇ as set forth in the applicable Project Plan for
Production of such Drug Product. Except as may specifically be
set forth in the Project Plan, on receipt of the Bulk Drug Substance and
CLIENT Supplied Components as set forth above, ALTHEA’s sole obligation
with respect to evaluation of the Bulk Drug Substance and CLIENT Supplied
Components shall be to review the accompanying certificate of analysis to
confirm that the Bulk Drug Substance and CLIENT Supplied Components (if
applicable) conform with the Specifications and component specifications,
respectively.
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2.3.2 ▇▇▇▇▇▇
Responsibilities: ▇▇▇▇▇▇, at its sole cost and expense (including,
without limitation, shipping costs), shall supply, in a timely manner, all
▇▇▇▇▇▇ Supplied Components as set forth in the applicable Project Plan for
Production of such Drug Product.
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2.4
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Bulk Drug Substance and
Component Delivery Delays: ▇▇▇▇▇▇ shall have no
responsibility for delays in delivery of Drug Product caused by delays in
receipt of Bulk Drug Substance or CLIENT Supplied Components.
Notwithstanding anything in this Agreement to the contrary, in the event
that ▇▇▇▇▇▇ receives the Bulk Drug Substance for Production of Drug
Product from CLIENT with less time than requested in the applicable
Project Plan prior to the scheduled date of Production of such Drug
Product, but within sufficient time to Produce such Drug Product on such
scheduled date as determined by ▇▇▇▇▇▇ in its sole discretion, ▇▇▇▇▇▇
shall Produce such Drug Product as per the original
schedule. Notwithstanding anything in this Agreement to the
contrary, in the event that ▇▇▇▇▇▇ receives the Bulk Drug Substance for
Production of Drug Product from CLIENT with less time than requested in
the applicable Project Plan prior to the scheduled date of Production of
such Drug Product, and without sufficient time to Produce such Drug
Product on the scheduled date as determined by ▇▇▇▇▇▇ in its sole
discretion, ▇▇▇▇▇▇ shall reschedule Production of such Drug Product and
shall charge CLIENT the applicable Cancellation Fee, provided, however, in
the event CLIENT has provided notice to ▇▇▇▇▇▇ a minimum of forty five
(45) days prior to the date scheduled for Production that delivery of the
Bulk Drug Substance to ▇▇▇▇▇▇ will be delayed, ▇▇▇▇▇▇ shall reschedule the
date for Production based on the new date for delivery of the drug
substance and no fees will be owed by
CLIENT.
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2.5
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Importer of
Record: In the event any material or equipment to be
supplied by CLIENT, including without limitation CLIENT Supplied
Components and Bulk Drug Substance, is imported into the United States for
delivery to ▇▇▇▇▇▇ ("Imported Goods"), CLIENT shall be the “Importer of
Record” of such Imported Goods. As the Importer of
Record, CLIENT shall be responsible for all aspects of the Imported Goods
including, without limitation (a) customs and other regulatory clearance
of Imported Goods, (b) payment of all tariffs, duties, customs, fees,
expenses and charges payable in connection with the importation and
delivery of the Imported Goods, and (c) keeping all records, documents,
correspondence and tracking information required by applicable laws, rules
and regulations arising out of or in connection with the importation or
delivery of the Imported Goods.
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2.6
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Material Safety Data
Sheet: CLIENT shall provide ▇▇▇▇▇▇ a Material Safety
Data Sheet for Bulk Drug Substance and for each Drug
Product. ▇▇▇▇▇▇ shall immediately notify CLIENT of any unusual
health or environmental occurrence relating to Drug Product, including,
but not limited to any claim or complaint by any employee of ▇▇▇▇▇▇ or any
of its Affiliates or third party that the operations of ▇▇▇▇▇▇ pursuant to
this Agreement have resulted in any adverse health or safety effect on an
employee or third party. ▇▇▇▇▇▇ agrees to advise CLIENT
immediately of any safety or toxicity problems of which it becomes aware
regarding the Drug Product.
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2.7
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Vendor and Supplier Audit and
Certification: CLIENT shall certify and audit all Drug
Product- related vendors and suppliers, or approve ALTHEA’S selection of
vendors and suppliers by way of signing this
agreement.
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2.8
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▇▇▇▇▇▇ Progress
Reports: ▇▇▇▇▇▇ shall provide CLIENT with at least
monthly written Microsoft Project reports on the progress of the
Development and Production of a Drug Product, comparing actual
accomplishments to the objectives set forth in the applicable Project
Plan..
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2.9
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Delivery
Terms: ▇▇▇▇▇▇ shall ship all Drug Product to CLIENT or
to CLIENT's designated consignee. All shipments shall be
shipped FOB ▇▇▇▇▇▇, by a common carrier designated by CLIENT, at CLIENT’s
expense; provided, however, ▇▇▇▇▇▇ shall be responsible for the loading of
the Drug Product on departure and shall bear risk of loss and all costs of
such loading. CLIENT shall procure, at its cost, insurance covering damage
or loss of Drug Product during shipping. All shipping
instructions of CLIENT shall be accompanied by the name and address of the
recipient and the shipping date.
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2.10
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Exporter of
Record: CLIENT shall be the exporter of record for any
Product shipped out of the United States, as CLIENT remains the owner of
the Product. CLIENT warrants that all shipments of Product
exported from the United States will be made in compliance
with all applicable United States export laws and regulations and all
applicable import laws and regulations into the country of
deportation.
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CLIENT
shall be responsible for obtaining and paying for any licenses or other
governmental authorization(s) necessary for the exportation from the United
States. CLIENT shall select and pay the freight forwarder who shall
solely be CLIENT’s agent. CLIENT and its freight forwarder shall be
solely responsible for preparing and filing the Shipper’s Export Declaration and
any other documentation required for the export.
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2.11
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Foreign Corrupt Practices
Act. CLIENT acknowledges that it is not the agent of
▇▇▇▇▇▇ and represents and warrants that it has not, and covenants that it
will not, pay anything of value to any government employee in connection
with the resale of the Product.
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2.12
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Deposits and Payment for Drug
Product and Development: Promptly upon execution of each Project
Plan, CLIENT shall pay to ▇▇▇▇▇▇ forty percent (40%) of the total fees of
this agreement, and thereafter will be invoiced monthly based on the
specific services completed during the month. The final invoice
for the Drug Product will be issued upon the delivery of released Drug
Product to CLIENT by ▇▇▇▇▇▇ CLIENT shall pay all invoices within thirty
(30) days of the invoice date therefore. Any payment due under
this Agreement not received within the times noted above shall bear
interest at the lesser of (a) the maximum rate permitted by law, and (b)
1.5% per month on the outstanding balance compounded
monthly.
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2.13
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Default in Payment Obligations:
In addition to all other remedies available to ▇▇▇▇▇▇ in the event
of a CLIENT default, if CLIENT fails to make payments as required
hereunder, ▇▇▇▇▇▇ may take appropriate measures to assure prompt and full
payment, including refusal to Produce any Drug Product until CLIENT’s
account is paid in full, modify the foregoing terms of payment, place the
account on a letter of credit basis, require full or partial payment in
advance, suspend deliveries of Drug Product until CLIENT provides
assurance of performance reasonably satisfactory to ▇▇▇▇▇▇, and/or take
other reasonable means as ▇▇▇▇▇▇ may
determine.
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2.14
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Returns: Drug Product
returned by third parties is the responsibility of
CLIENT.
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Article
3, TERM AND TERMINATION.
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3.1
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Term: This Agreement shall commence
on the date first above written and will continue until the Development
and Production, as described in the Project Plan, have been completed,
unless sooner terminated pursuant to Section 3.2 herein (the
“Term”).
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3.2
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Termination: This
Agreement may be terminated at any time upon the occurrence of any of the
following events:
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3.2.1
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Termination for
Breach: Either party may terminate this Agreement upon
the breach of any provision of this Agreement by the other party if such
breach is not cured by the breaching party within thirty (30) calendar
days (or such additional time not to exceed ninety (90) days reasonably
necessary to cure such default provided the breaching party has commenced
a cure within the thirty (30) day period and is diligently pursuing
completion of such cure) after receipt by the breaching party of written
notice of such default. At the option of the non-breaching
party, such termination may be with respect to the entire Agreement, or
only with respect to the Drug Product that is subject to the
breach.
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3.2.2
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Termination for Financial
Matters: This Agreement may be terminated immediately by
either party by giving the other party written notice thereof in the event
such other party makes a general assignment for the benefit of its
creditors, or proceedings of a case are commenced in any court of
competent jurisdiction by or against such party seeking (a) such party’s
reorganization, liquidation, dissolution, arrangement or winding up, or
the composition or readjustment of its debts, (b) the appointment of a
receiver or trustee for or over such party’s property,
or
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(c)
similar relief in respect of such party under any law relating to bankruptcy,
insolvency, reorganization, winding up or composition or adjustment of debt, and
such proceedings shall continue undismissed, or an order with respect to the
foregoing shall be entered and continue unstated, for a period of more than
sixty (60) days.
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3.2.3
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Termination by
Client: This Agreement may be terminated by CLIENT at
any time by giving ▇▇▇▇▇▇ notice thereof and payment to ▇▇▇▇▇▇ of the
Cancellation Fee set forth in Section
3.3.
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3.3
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Payment on
Termination: In the event of the termination of this
Agreement by ▇▇▇▇▇▇ pursuant to Section 3.2.1, CLIENT shall reimburse
▇▇▇▇▇▇ for (a) all Components ordered prior to termination and not
cancelable at no cost to ▇▇▇▇▇▇, (b) all work-in-process commenced by
▇▇▇▇▇▇, and (c) all finished Drug Product. In the event of
cancellation by CLIENT of the Production of any Batch set forth in a
Project Plan or in the event of termination of this Agreement, except for
termination in the event of a default by ▇▇▇▇▇▇ pursuant to Section 3.2.1,
CLIENT shall pay the Cancellation Fees as hereinafter set
forth: (i) CLIENT is subject to a 20% charge if the Batch is
canceled less than nine (9) weeks from the scheduled fill date, (ii) a 30%
charge if the Batch is canceled less than six (6) weeks from the scheduled
fill date, and (iii) a 50% charge if the Batch is canceled less than three
(3) weeks from the scheduled fill date. In addition, CLIENT
must compensate ▇▇▇▇▇▇ for any materials ordered or testing
completed. For purposes of the foregoing, one (1) week is
equivalent to seven (7) days. Following expiration or
termination, ▇▇▇▇▇▇ shall ship such materials to CLIENT at CLIENT's cost
and per CLIENT's instructions. CLIENT shall make payment for
all expenses described in Section 3.3 thirty (30) days from the invoice
date. In the event of termination by CLIENT for a breach by
▇▇▇▇▇▇ pursuant to Section 3.2.1, CLIENT shall not owe any Cancellation
Fees.
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3.4
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Survival: Termination,
expiration, cancellation or abandonment of this Agreement through any
means or for any reason, except as set forth in Section 12.1, shall be
without prejudice to the rights and remedies of either party with respect
to any antecedent breach of any of the provisions of this
Agreement. The provisions of Sections 3, 6, 9, 10, 11, 12, 13,
14, and 15 hereof shall survive expiration or termination of this
Agreement.
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Article
4, CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE.
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4.1
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Certificates of
Analysis: At CLIENT’s cost and expense, ▇▇▇▇▇▇ shall
test, or cause to be tested by third parties, in accordance with the
Specifications, each Batch of Drug Product Produced pursuant to this
Agreement before delivery to CLIENT. A certificate of analysis
for each Batch delivered shall set forth the items tested, Specifications,
and test results. ▇▇▇▇▇▇ shall also indicate on the final page
of the Executed Batch Record that all batch Production and control records
have been reviewed and approved by the appropriate quality control
unit. ▇▇▇▇▇▇ shall send, or cause to be sent, such certificates
to CLIENT prior to the shipment of Drug Product (unless Drug Product is
shipped under quarantine). CLIENT shall test, or cause to be
tested, for final release, each Batch of Drug Product as meeting the
Specifications. As required by the FDA (see Section 5.2 below),
CLIENT assumes full responsibility for final release of each Batch of Drug
Product.
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4.2
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Manufacturing
Compliance: ▇▇▇▇▇▇ shall advise CLIENT immediately if an
authorized agent of any Regulatory Authority visits ALTHEA's manufacturing
facility and makes an inquiry or inspection regarding ALTHEA's Production
of Drug Product for CLIENT. ▇▇▇▇▇▇ will also forward to CLIENT
any documents of findings of violations, including but not limited to FDA
Form 483. Manufacturing deviations and investigations which
occur during Production of Drug Product and which do not cause the
Production to be non-compliant with cGMP, shall not be deemed to cause
such Drug Product to be non-conforming as set forth in Section
5.1.
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4.3
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Reserve
Samples: CLIENT shall be responsible for obtaining and
maintaining sufficient quantities of Bulk Drug Substance and Drug Product
reserve samples pursuant to cGMP.
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4.4
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Annual Quality
Review: CLIENT shall be responsible for evaluating, at
least annually, the quality standards of Drug Product to determine the
need for changes in Specifications, manufacturing processes, and/or
controlled documents. CLIENT shall supply ▇▇▇▇▇▇ a copy of the
evaluation and recommendations, if
any.
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4.5
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Distribution
Records: ▇▇▇▇▇▇ shall maintain distribution records that
contain all of the appropriate information as specified in
cGMP.
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4.6
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Customer
Complaints: CLIENT, as required by cGMP, shall maintain
complaint files. All specific CLIENT Drug Product-related
complaints received by ▇▇▇▇▇▇ shall be forwarded to
CLIENT. CLIENT shall be responsible for the review of the
complaint to determine the need for an investigation or the need to report
to the FDA as required by cGMP. CLIENT shall send to ▇▇▇▇▇▇ all
Drug Product performance or manufacturing-related complaints which require
investigation. ▇▇▇▇▇▇ shall conduct an investigation for each
Drug Product performance or manufacturing-related complaint and shall
report findings and follow-up of each investigation to
CLIENT. CLIENT shall make these complaint files available to
▇▇▇▇▇▇ in the event they are required during an FDA
inspection.
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4.7
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Audits: CLIENT, upon
prior written notice and during normal business hours, shall have the
right to inspect, once annually for not more than two (2) days, ▇▇▇▇▇▇
batch records and the portions of ALTHEA’s facility used for Production of
Drug Product. If CLIENT chooses to audit ▇▇▇▇▇▇ more than one
(1) time in a calendar year or for more than two (2) days, CLIENT agrees
to reimburse ▇▇▇▇▇▇ for ALTHEA’s reasonable expenses incurred in hosting
the audit. All audited data will be treated as Confidential
Information of ▇▇▇▇▇▇ and CLIENT shall not be permitted to remove or copy
data without ALTHEA’s prior
consent.
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4.8
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Regulatory
Compliance: Unless otherwise stated, ▇▇▇▇▇▇ is
responsible for compliance with all Federal, State and local laws and
regulations (“Regulations”) as they apply generally to Production, quality
and specifications of pharmaceutical products. CLIENT shall be
responsible for compliance with all Regulations as they apply to all other
aspects of the Production, use, and sale of Drug Product, which
responsibility shall include, without limitation, all contact and
communications with the FDA regarding the
foregoing.
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8
Article
5, ACCEPTANCE OF DRUG PRODUCT.
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5.1
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Non-Conforming Drug
Product: Within fifteen
(15) calendar days from the date of Production of any Batch pursuant to
the Project Plan, ▇▇▇▇▇▇ shall promptly forward to CLIENT, or CLIENT’s
designee, samples of such Batch. Within thirty (30) calendar days after
receipt by CLIENT of the samples or fifteen (15) calendar days after
receipt by CLIENT of the Released Executed Batch Record, whichever is
later, CLIENT shall determine whether Drug Product conforms to ALTHEA’s
Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs,
and the Project Plan (collectively the “Product
Requirements”).
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|
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5.1.1
|
If
(a) any Batch of Drug Product conforms to the Product Requirements, or (b)
CLIENT fails to notify ▇▇▇▇▇▇ within the applicable time period that any
Batch of Drug Product does not conform to the Product Requirements, then
CLIENT shall be deemed to have accepted the Drug Product and waived its
right to revoke acceptance.
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5.1.2
|
If
CLIENT believes any Batch of Drug Product does not conform to the Product
Requirements, it shall notify ▇▇▇▇▇▇ by telephone, including a detailed
explanation of the non-conformity, and shall confirm such notice in
writing via overnight delivery to ▇▇▇▇▇▇. Upon receipt of such
notice, ▇▇▇▇▇▇ will investigate such alleged non-conformity, and (i) if
▇▇▇▇▇▇ agrees such Drug Product is non-conforming, deliver to CLIENT a
corrective action plan within thirty (30) calendar days after receipt of
CLIENT’s written notice of non-conformity, or such additional time as is
reasonably required if such investigation or plan requires data from
sources other than CLIENT or ▇▇▇▇▇▇, or (ii) if ▇▇▇▇▇▇ disagrees with
CLIENT’s determination that the Batch of Drug Product is
non-conforming, ▇▇▇▇▇▇ shall so notify CLIENT by telephone
within the thirty (30) calendar day period and confirm such notice in
writing by overnight delivery.
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5.1.3
|
If
the parties dispute whether Batch of Drug Product is conforming or
non-conforming, samples of the Batch of Drug Product will be submitted to
a mutually acceptable laboratory or consultant for resolution, whose
determination of conformity or non-conformity, and the cause thereof if
non-conforming, shall be binding upon the parties. CLIENT
shall bear the costs of such laboratory or consultant, except as set forth
in Section 5.2.
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5.2
|
Remedies for Non Conforming
Product: In the event ▇▇▇▇▇▇ agrees that the Batch of
Drug Product is non-conforming solely as a result of the negligence or any
other fault of ▇▇▇▇▇▇ or the laboratory determines that the shipment of
Drug Product is non-conforming solely as a result of the negligence or any
other fault of ▇▇▇▇▇▇, then ▇▇▇▇▇▇, at its option, shall either (i) at its
expense, and subject to CLIENT, at its expense, supplying the replacement
Bulk Drug Substance and upon payment for the non-conforming Drug Product
by CLIENT, replace such non-conforming Drug Product within sixty (60)
calendar days from receipt of replacement Bulk Drug Substance from CLIENT,
or (ii) refund the Purchase Price of the non-conforming Drug
Product.
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5.3
|
Non-conforming Bulk Drug
Substance: If Drug Product is rejected by CLIENT, and
such Drug Product’s failure to meet the Product Requirements is the result
of non-conforming Bulk Drug Substance, then such non-conformity shall be
deemed not to be non-conforming solely as a result of the negligence of
▇▇▇▇▇▇.
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9
Article
6, DRUG PRODUCT RECALLS.
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6.1
|
Drug Product
Recalls: In the event CLIENT shall be required to recall
any Drug Product because such Drug Product may violate local, state or
federal laws or regulations, the laws or regulations of any applicable
foreign government or agency or the Drug Product Specifications, or in the
event that CLIENT elects to institute a voluntary recall, CLIENT shall be
responsible for coordinating such recall. CLIENT promptly shall
notify ▇▇▇▇▇▇ if any Drug Product is the subject of a recall and provide
▇▇▇▇▇▇ with a copy of all documents relating to such
recall. ▇▇▇▇▇▇ shall cooperate with CLIENT in connection with
any recall, at CLIENT’s expense. CLIENT shall be responsible for all of
the costs and expenses of such
recall.
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Article
7, FORCE MAJEURE; FAILURE TO SUPPLY.
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7.1
|
Force Majeure
Events: Failure of either party to perform under this
Agreement (except the obligation to make payments) shall not subject such
party to any liability to the other if such failure is caused by acts of
God, acts of terrorism, fire, explosion, flood, drought, war, riot,
sabotage, embargo, strikes or other labor trouble, compliance with any
order or regulation of any government entity, or by any cause beyond the
reasonable control of the affected party, whether or not foreseeable,
provided that written notice of such event is promptly given to the other
party.
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7.2
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Failure to
Supply: If ▇▇▇▇▇▇ fails to supply all or any material
part of Drug Product ordered by CLIENT, CLIENT may require ▇▇▇▇▇▇ to
supply the undelivered Drug Product or a lesser quantity at a future date
agreed upon by ▇▇▇▇▇▇ and CLIENT. The provisions of this
Section 7.2 shall be without prejudice to CLIENT's rights under Section
3.2 and remedies provided for
thereunder.
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Article
8, CHANGES IN PRODUCTION.
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8.1
|
Changes to Master Batch Records
and Product Specifications: ▇▇▇▇▇▇ agrees to inform
CLIENT within fifteen (15) days of the result of any regulatory
development or changes to Drug Product-specific SOPs that materially
affect the Production of Drug Product. ▇▇▇▇▇▇ shall notify
CLIENT of and require written approval from CLIENT for changes to Master
Batch Records and Drug Product Specifications prior to the Production of
subsequent Batches of Drug Product.
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8.2
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Facility
Changes
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8.2.1
|
Product-Specific
Changes: If facility, equipment, process or system
changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by
the FDA or any other Regulatory Authority, and such regulatory changes
apply primarily to the Production and supply of one or more Drug Products,
then CLIENT and ▇▇▇▇▇▇ will review such requirements and agree in writing
to such regulatory changes, and CLIENT shall bear 100% of the reasonable
costs thereof.
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8.2.2
|
General
Changes: If such regulatory changes apply generally to
one or more Drug Products as well as to other products Produced by ▇▇▇▇▇▇
for itself or for third parties, then CLIENT shall pay a pro rata amount
of the reasonable cost of such regulatory changes based upon the
proportion of time that such facility is dedicated to the Production of
Drug Products relative to the Production of such other
products.
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10
Article
9, CONFIDENTIALITY.
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|
9.1
|
Confidentiality: It
is contemplated that in the course of the performance of this Agreement
each party may, from time to time, disclose Confidential Information to
the other. Each party agrees to take all reasonable steps to
prevent disclosure of Confidential Information to third
parties. No provision of this Agreement shall be construed so
as to preclude disclosure of Confidential Information as may be reasonably
necessary to secure from any governmental agency necessary approvals or
licenses or to obtain patents with respect to the Drug
Product.
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9.2
|
Prior Confidentiality
Agreement: This Agreement, by reference, incorporates
the Confidentiality Agreement signed by CLIENT and ▇▇▇▇▇▇ on February
12th,
2008, and is made a part hereof as though fully set forth
herein.
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9.3
|
Third Party
Disclosure: ▇▇▇▇▇▇ shall be permitted to disclose Drug
Product information to third party developmental and analytical service
providers in connection with performance of its obligations hereunder
provided such providers shall be subject to confidentiality
agreements. Either party may disclose Confidential Information
of the disclosing party to those Affiliates, agents and consultants who
need to know such information to accomplish the purposes of this Agreement
(collectively, “Permitted Recipients”); provided such Permitted Recipients
are bound to maintain such Confidential Information in
confidence.
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|
9.4
|
Litigation and Governmental
Disclosure: Each party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably
necessary for prosecuting or defending litigation, complying with
applicable governmental regulations or conducting pre-clinical or clinical
trials, provided that if a party is required by law or regulation to make
any such disclosure of the other party’s Confidential Information it will,
except where impractical for necessary disclosures, for example in the
event of a medical emergency, give reasonable advance notice to the other
party of such disclosure requirement and will use good faith efforts to
assist such other party to secure a protective order or confidential
treatment of such Confidential Information required to be
disclosed.
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|
9.5
|
Limitation of
Disclosure: The parties agree that, except as otherwise
may be required by applicable laws, regulations, rules or orders,
including without limitation the rules and regulations promulgated by the
United States Securities and Exchange Commission, and except as may be
authorized in Section 9.4, no information concerning this Agreement and
the transactions contemplated herein shall be made public by either party
without the prior written consent of the
other.
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9.6
|
Publicity and SEC
Filings. The parties agree that the public announcement
of the execution of this Agreement shall only be by one or more press
releases mutually agreed to by the parties. The failure of a
party to return a draft of a press release with its proposed amendments or
modifications to such press release to the other party within five (5)
days of such party’s receipt of such press release shall be deemed as such
party’s approval of such press release as received by such
party. Each party agrees that it shall cooperate fully and in a
timely manner with the other with respect to all disclosures to the
Securities and Exchange Commission and any other governmental or
regulatory agencies, including requests for confidential treatment of
Confidential Information of either party included in any such
disclosure.
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11
|
|
9.7
|
Duration of
Confidentiality: All obligations of confidentiality and
non-use imposed upon the parties under this Agreement shall expire ten
(10) years after the expiration or earlier termination of this Agreement;
provided, however, that Confidential Information which constitutes the
trade secrets of a party shall be kept confidential indefinitely, subject
to the limitations set forth in Sections 9.4 through
9.5.
|
Article
10, INVENTIONS.
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|
10.1
|
Existing Intellectual
Property: Except as the parties may otherwise expressly
agree in writing, each party shall continue to own its existing patents,
trademarks, copyrights, trade secrets and other intellectual property,
without conferring any interests therein on the other party. Without
limiting the generality of the preceding sentence, CLIENT shall retain all
right, title and interest arising under the United States Patent Act, the
United States Trademark Act, the United States Copyright Act and all other
applicable laws, rules and regulations in and to all Drug Products, Bulk
Drug Substance, Labeling and trademarks associated therewith
(collectively, “CLIENT’s Intellectual Property”). Neither
▇▇▇▇▇▇ nor any third party shall acquire any right, title or interest in
CLIENT’s Intellectual Property by virtue of this Agreement or otherwise,
except to the extent expressly provided
herein.
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10.2
|
Individually Owned Inventions:
Except as the parties may otherwise agree in writing, all
Inventions (as defined herein) which are conceived, reduced to practice,
or created by a party in the course of performing its obligations under
this Agreement shall be solely owned and subject to use and exploitation
by the inventing party without a duty to account to the other party,
provided, however, any Inventions or changes to CLIENT’s Drug Product
formulation shall be owned solely by CLIENT. For purposes of
this Agreement, “Invention” shall mean information relating to any
innovation, improvement, development, discovery, computer program, device,
trade secret, method, know-how, process, technique or the like, whether or
not written or otherwise fixed in any form or medium, regardless of the
media on which contained and whether or not patentable or
copyrightable.
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10.3
|
Jointly Owned Inventions:
All Inventions which are conceived, reduced to practice, or created
jointly by the parties and/or their respective agents (i.e., employees or
agents who would be or are properly named as co-inventors under the laws
of the United States on any patent application claiming such inventions)
in the course of the performance of this Agreement shall be owned jointly
by the parties. Each party shall have full rights to exploit such
Inventions for its own commercial purposes without any obligation to the
other. The parties shall share equally in the cost of mutually agreed
patent filings with respect to all such jointly owned Inventions. The
decision to file for patent coverage on jointly owned Inventions shall be
mutually agreed upon, and the Parties shall select a mutually acceptable
patent counsel to file and prosecute patent applications based on such
joint Inventions.
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10.4
|
Disclaimer: Except
as otherwise expressly provided herein, nothing contained in this
Agreement shall be construed or interpreted, either expressly or by
implication, estoppel or otherwise, as: (i) a grant, transfer or other
conveyance by either party to the other of any right, title, license or
other interest of any kind in any of its Inventions or other intellectual
property, (ii) creating an obligation on the part of either party to make
any such grant, transfer or other conveyance or (iii) requiring either
party to participate with the other party in any cooperative development
program or project of any kind or to continue with any such program or
project.
|
12
|
|
10.5
|
Rights in
IP: The party owning any IP shall have the world wide
right to control the drafting, filing, prosecution and maintenance of
patents covering the Inventions relating to such IP, including decisions
about the countries in which to file patent
applications. Patent costs associated with the patent
activities described in this Section shall be borne by the sole
owner. Each party will cooperate with the other party in the
filing and prosecution of patent applications. Such cooperation will
include, but not be limited to, furnishing supporting data and affidavits
for the prosecution of patent applications and completing and signing
forms needed for the prosecution, assignment and maintenance of patent
applications.
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|
10.6
|
Confidentiality of
IP: IP shall be deemed to be the Confidential
Information of the party owning such IP. The protection of each
party’s Confidential Information is described in Article 9. Any
disclosure of information by one party to the other under the provisions
of this Section 10 shall be treated as the disclosing party’s Confidential
Information under this Agreement. It shall be the
responsibility of the party preparing a patent application to obtain the
written permission of the other party to use or disclose the other party’s
Confidential Information in the patent application before the application
is filed and for other disclosures made during the prosecution of the
patent application.
|
Article
11, REPRESENTATIONS AND WARRANTIES.
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|
11.1
|
Mutual
Representations: Each party hereby represents and
warrants to the other party that (a) the person executing this Agreement
is authorized to execute this Agreement; (b) this Agreement is legal and
valid and the obligations binding upon such party are enforceable by their
terms; and (c) the execution, delivery and performance of this Agreement
does not conflict with any agreement, instrument or understanding, oral or
written, to which such party may be bound, nor violate any law or
regulation of any court, governmental body or administrative or other
agency having jurisdiction over it.
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11.2
|
▇▇▇▇▇▇
Warranty: ▇▇▇▇▇▇ represents and warrants that Drug
Product shall be Produced in accordance with cGMP and the Drug Product
Specifications at the time of release. ▇▇▇▇▇▇ represents and
warrants that it has obtained (or will obtain prior to Producing Drug
Product), and will remain in compliance with during the term of this
Agreement, all permits, licenses and other authorizations (the “Permits”)
which are required under federal, state and local laws, rules and
regulations applicable to the Production only of Drug Product as specified
in the Project Plan; provided, however, ▇▇▇▇▇▇ shall have no obligation to
obtain Permits relating to the sale, marketing, distribution or use of
Bulk Drug Substance or Drug Product or with respect to the Labeling
of Drug Product. ▇▇▇▇▇▇ makes no representation or
warranty with respect to the sale, marketing, distribution or use of the
Bulk Drug Substance or as to printed materials supplied by CLIENT or its
consignee. At the time of release, of the Drug Product, ▇▇▇▇▇▇
represents and warrants that such Drug Product shall be free from defects
in design and workmanship.
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11.3
|
Disclaimer of
Warranties: Except for those warranties set forth in
Sections 11.1 and 11.2 of this Agreement, ▇▇▇▇▇▇ makes no warranties,
written, oral, express or implied, with respect to Drug Product or the
Development and Production of Drug Product. ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT HEREBY ARE DISCLAIMED BY ▇▇▇▇▇▇. NO WARRANTIES
OF ▇▇▇▇▇▇ MAY BE CHANGED BY ANY REPRESENTATIVES OF
▇▇▇▇▇▇. CLIENT accepts Drug Product subject to the terms
hereof.
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13
|
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11.4
|
CLIENT
Warranties: CLIENT warrants that (a) it has the right to
give ▇▇▇▇▇▇ any information provided by CLIENT hereunder, and that ▇▇▇▇▇▇
has the right to use such information for the Production of Drug Product,
and (b) CLIENT has no knowledge of any (i) patents or other intellectual
rights that would be infringed by ALTHEA’s Production of Drug Product
under this Agreement, or (ii) proprietary rights of third parties which
would be violated by ALTHEA’s performance hereunder. CLIENT
further warrants that the Bulk Drug Substance provided to ▇▇▇▇▇▇ hereunder
(1) conforms to the Bulk Drug Substance Specifications and (2) is not
adulterated or misbranded within the meaning of the FD&C
Act.
|
Article
12, LIMITATION OF LIABILITY AND WAIVER OF SUBROGATION.
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|
12.1
|
Limitation of
Liability: CLIENT’s sole and exclusive remedy for breach
of this Agreement is limited to those remedies set forth in Article 5 and
at ALTHEA’s decision, in ALTHEA’s sole discretion, to either replace the
non-conforming Drug Product or reimburse CLIENT for the Purchase Price for
the non-conforming Drug Product. Under no circumstances shall
▇▇▇▇▇▇ be liable for loss of use or profits or other collateral, special,
consequential or other damages, losses, or expenses, including but not
limited to the cost of cover or the cost of a recall in connection with,
or by reason of the Production and delivery of Drug Product under this
Agreement whether such claims are founded in tort or
contract. The foregoing constitutes the sole and exclusive
remedy of CLIENT and the sole and exclusive liability of
▇▇▇▇▇▇. All claims by CLIENT for breach or default under this
Agreement shall be brought within one (1) year after the cause of action
accrued or shall be deemed waived.
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|
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12.2
|
Waiver of
Subrogation: All ▇▇▇▇▇▇ Supplied Components and
equipment used by ▇▇▇▇▇▇ in the Production of Drug Product (collectively,
“▇▇▇▇▇▇ Property”) shall at all times remain the property of ▇▇▇▇▇▇ and
▇▇▇▇▇▇ assumes risk of loss for such property until delivery of Drug
Product to a common carrier as specified under Section
2.10. ▇▇▇▇▇▇ hereby waives any and all rights of recovery
against CLIENT and its Affiliates, and against any of their respective
directors, officers, employees, agents or representatives, for any loss or
damage to ▇▇▇▇▇▇ Property to the extent the loss of damage is covered or
could be covered by insurance (whether or not such insurance is described
in this Agreement). CLIENT assumes all risk of loss for all CLIENT
Supplied Components, all Bulk Drug Substance supplied by CLIENT, and all
Drug Product (collectively, “CLIENT Property”). CLIENT hereby
waives any and all rights of recovery against ▇▇▇▇▇▇ and its Affiliates,
and against any of their respective directors, officers, employees, agents
or representatives, for any loss or damage to the CLIENT Property to the
extent the loss of damage is covered or could be covered by insurance
(whether or not such insurance is described in this
Agreement).
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|
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12.3
|
Waiver of
Claims: In connection with providing Development
services, ▇▇▇▇▇▇ represents only that it will use reasonable care in
providing such information solely as it relates to development studies,
formulation, primary packaging and manufacturing process
development. ▇▇▇▇▇▇ makes no representation or warranty, and
CLIENT expressly waives all claims against ▇▇▇▇▇▇ and its Affiliates, and
any of their respective agents or employees, arising out of or in
connection with any claims relating to the stability, efficacy, safety, or
toxicity of Drug Product developed, formulated, packaged or manufactured
in accordance with the Development services provided by
▇▇▇▇▇▇.
|
14
|
|
Article
13, INDEMNIFICATION.
|
|
|
13.1
|
CLIENT
Indemnification: CLIENT shall indemnify, defend and hold
harmless ▇▇▇▇▇▇ and its Affiliates, and any of their respective directors,
officers, employees, subcontractors and agents (collectively the
“Indemnified Parties”) from and against any and all liabilities,
obligations, penalties, claims, judgments, demands, actions, disbursements
of any kind and nature, suits, losses, damages, costs and expenses
(including, without limitation, reasonable attorney’s fees) arising out of
or in connection with property damage or personal injury (including
without limitation death) of third parties (collectively “Claims”)
including without limitation Claims allegedly resulting in whole or in
part by the negligent acts or omission of the Indemnified Parties or for
acts or omissions for which the Indemnified Parties otherwise would be
strictly liable, in connection with (a) CLIENT’s storage,
promotion, labeling, marketing, distribution, use or sale of Bulk Drug
Substance or Drug Product, (b) CLIENT’s negligence or willful misconduct,
(c) CLIENT’s breach of this Agreement, or (d) any claim that the use,
sale, Production, marketing or distribution of Bulk Drug Substance or Drug
Product by ▇▇▇▇▇▇ or CLIENT violates the patent, trademark, copyright or
other proprietary rights of any third party, except to the extent any of
the foregoing (a) or (d) is caused solely by the negligence or willful
misconduct of the Indemnified Parties or solely by the breach by ▇▇▇▇▇▇ of
its obligations under this
Agreement.
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|
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13.2
|
▇▇▇▇▇▇
Indemnification: ▇▇▇▇▇▇ shall indemnify, defend and hold
harmless CLIENT and its Affiliates and any of their respective directors,
officers, employees, subcontractors and agents from and against any and
all Claims resulting solely from the Indemnified Parties’ negligence or
willful misconduct or solely from the ALTHEA’s breach of its obligations
under this Agreement.
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|
|
13.3
|
Indemnitee
Obligations: A party (the “Indemnitee”) which intends to
claim indemnification under this Article 13 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 Affiliates, or any
of their respective directors, officers, employees, subcontractors, or
agents, intend to claim such indemnification; provided, however, that
failure to provide such notice within a reasonable period of time shall
not relieve the Indemnitor of any of its obligations hereunder except to
the extent the Indemnitor is prejudiced by such failure. The
Indemnitee shall permit, and shall cause its Affiliates, and their
respective directors, officers, employees, subcontractors and agents to
permit, the Indemnitor, at its discretion, to settle any such action,
claim or other matter, and the Indemnitee agrees to the complete control
of such defense or settlement by the
Indemnitor. Notwithstanding the foregoing, the Indemnitor shall
not enter into any settlement that would adversely affect the Indemnitee’s
rights hereunder, or impose any obligations on the Indemnitee in addition
to those set forth herein, in order for it to exercise such rights,
without Indemnitee’s prior written consent, which shall not be
unreasonably withheld or delayed. No such action, claim or
other matter shall be settled without the prior written consent of the
Indemnitor, which shall not be unreasonably withheld or
delayed. The Indemnitee, its Affiliates, and their respective
directors, officers, employees, subcontractors and agents shall fully
cooperate with the Indemnitor and its legal representatives in the
investigation and defense of any action, claim or other matter covered by
the indemnification obligations of this Article 13. The
Indemnitee shall have the right, but not the obligation, to be represented
in such defense by counsel of its own selection and at its own
expense.
|
15
|
|
13.4
|
Injunction: In
the event that the Production or sale of a Drug Product is enjoined due to
alleged infringement by either party of the proprietary rights of a third
party, such action shall be deemed a breach of this Agreement by CLIENT
and subject to the terms of Article
3.
|
Article
14, INSURANCE.
|
|
14.1
|
CLIENT
Insurance: CLIENT shall procure and maintain, during the
Term of this Agreement and for a period one (1) year beyond the expiration
date of Drug Product, Commercial General Liability Insurance, including
without limitation, Product Liability and Contractual Liability coverage
(the “CLIENT Insurance”). The CLIENT Insurance shall cover
amounts not less than one million dollars ($1,000,000) combined single
limit and shall be with an insurance carrier reasonably acceptable to
▇▇▇▇▇▇. ▇▇▇▇▇▇ shall be named as an additional insured on the
CLIENT Insurance and CLIENT promptly shall deliver a certificate of CLIENT
Insurance and endorsement of additional insured to ▇▇▇▇▇▇ evidencing such
coverage. If CLIENT fails to furnish such certificates or
endorsements, or if at any time during the Term of this Agreement ▇▇▇▇▇▇
is notified of the cancellation or lapse of the CLIENT Insurance, and
CLIENT fails to rectify the same within ten (10) calendar days after
notice from ▇▇▇▇▇▇, in addition to all other remedies available to ▇▇▇▇▇▇
hereunder, ▇▇▇▇▇▇, at its option, may obtain the CLIENT Insurance and
CLIENT promptly shall reimburse ▇▇▇▇▇▇ for the cost of the same. Any
deductible and/or self insurance retention shall be the sole
responsibility of CLIENT.
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|
|
14.2
|
▇▇▇▇▇▇
Insurance: ▇▇▇▇▇▇ shall procure and maintain, during the
Term of this Agreement and for a period of one (1) year beyond the
expiration date of Drug Product, Commercial General Liability Insurance,
including without limitation, Product Liability and Contractual Liability
coverage (the “▇▇▇▇▇▇ Insurance”). The ▇▇▇▇▇▇ Insurance shall
cover amounts not less than one million dollars ($1,000,000) combined
single limit. CLIENT shall be named as an additional insured on
the ▇▇▇▇▇▇ Insurance.
|
Article
15, GENERAL PROVISIONS.
|
|
15.1
|
Notices: All
notices hereunder shall be delivered by facsimile (confirmed by overnight
delivery), or by overnight delivery with a reputable overnight delivery
service, to the following address of the respective
parties:
|
|
|
If
to CLIENT:
|
Bio-Path
Holdings, Inc.
|
▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇
▇▇▇▇▇▇▇
President
and Chief Executive Officer
|
|
Telephone:
|
(▇▇▇)
▇▇▇-▇▇▇▇
|
|
|
Facsimile:
|
(▇▇▇)
▇▇▇-▇▇▇▇
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If to
▇▇▇▇▇▇: ▇▇▇▇▇▇
Technologies, Inc.
▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇
▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇
▇▇▇▇▇
Executive
Vice President and Chief Business Officer
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Telephone:
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(▇▇▇)
▇▇▇-▇▇▇▇
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Facsimile:
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(▇▇▇)
▇▇▇-▇▇▇▇
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16
For
specific inquiries, the following ▇▇▇▇▇▇ responsible parties may be contacted
directly:
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Project
Manager
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▇▇▇▇▇
▇▇▇▇▇
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Quality
Control Manager
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▇▇▇▇▇
▇▇▇▇
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Quality
Assurance Manager
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▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
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Materials
Manager
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▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
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For
specific inquiries, the following CLIENT responsible parties may be contacted
directly:
Quality
Assurance/Regulatory Director: Dai-▇▇▇▇ ▇▇▇▇
Notices
shall be effective on the day following the date of transmission if sent by
facsimile, and on the second business day following the date of delivery to the
overnight delivery service if sent by overnight delivery. A party may
change its address listed above by notice to the other party given in accordance
with this section.
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15.2
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Entire Agreement;
Amendment: The parties hereto acknowledge that this
Agreement sets forth the entire agreement and understanding of the parties
and supercedes all prior written or oral agreements or understandings with
respect to the subject matter hereof. No modification of any of
the terms of this Agreement, or any amendments thereto, shall be deemed to
be valid unless in writing and signed by an authorized agent or
representative of both parties hereto. No course of dealing or
usage of trade shall be used to modify the terms and conditions
herein.
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15.3
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Waiver: None
of the provisions of this Agreement shall be considered waived by any
party hereto unless such waiver is agreed to, in writing, by authorized
agents of both parties. The failure of a party to insist upon
strict conformance to any of the terms and conditions hereof, or failure
or delay to exercise any rights provided herein or by law shall not be
deemed a waiver of any rights of any party
hereto.
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15.4
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Obligations to Third
Parties: Each party warrants and represents that this
Agreement is not inconsistent with any contractual obligations, expressed
or implied, undertaken with any third
party.
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15.5
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Assignment: This
Agreement shall be binding upon and inure to the benefit of the successors
or permitted assigns of each of the parties and may not be assigned or
transferred by either party without the prior written consent of the
other, which consent will not be unreasonably withheld or delayed, except
that no consent shall be required in the case of a transfer to a
wholly-owned subsidiary or transaction involving the merger, consolidation
or sale of substantially all of the assets of the party seeking such
assignment or transfer and such transaction relates to the business
covered by this Agreement and the resulting entity assumes all the
obligations under this Agreement. ▇▇▇▇▇▇ may, without such
consent, assign this Agreement to an Affiliate of ▇▇▇▇▇▇, provided that
the assignee assumes all obligations of ▇▇▇▇▇▇ under this
Agreement. No assignment shall relieve any party of
responsibility for the performance of its obligations
hereunder.
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17
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15.6
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Successors and
Assigns: This Agreement shall be binding upon and shall
inure to the benefit of the parties hereto, their successors and permitted
assigns.
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15.7
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Taxes: CLIENT
shall pay all national, state, municipal or other sales, use excise,
import, property, value added, or other similar taxes, assessments or
tariffs assessed upon or levied against the sale of Drug Product to CLIENT
pursuant to this Agreement or the sale or distribution of Drug Product by
CLIENT (or at CLIENT’s sole expense, defend against the imposition of such
taxes and expenses). ▇▇▇▇▇▇ shall notify CLIENT of any such
taxes that any governmental authority is seeking to collect from ▇▇▇▇▇▇,
and CLIENT may assume the defense thereof in ALTHEA’s name, if necessary,
and ▇▇▇▇▇▇ agrees to fully cooperate in such defense to the extent of the
capacity of ▇▇▇▇▇▇, at CLIENT’s expense. ▇▇▇▇▇▇ shall pay all
national, state, municipal or other taxes on the income resulting from the
sale by ▇▇▇▇▇▇ of the Drug Product to CLIENT under this Agreement,
including but not limited to, gross income, adjusted gross income,
supplemental net income, gross receipts, excess profit taxes, or other
similar taxes.
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15.8
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Independent
Contractor: ▇▇▇▇▇▇ shall act as an independent
contractor for CLIENT in providing the services required hereunder and
shall not be considered an agent of, or joint venturer with,
CLIENT. Unless otherwise provided herein to the contrary,
▇▇▇▇▇▇ shall furnish all expertise, labor, supervision, machining and
equipment necessary for performance hereunder and shall obtain and
maintain all building and other permits and licenses required by public
authorities.
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15.9
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Governing
Law: This Agreement is being delivered and executed in
the State of California. In any action brought regarding the validity,
construction and enforcement of this Agreement, it shall be governed in
all respects by the laws of the State of California, without regard to the
principals of conflicts of laws. The courts of the State of
California shall have personal jurisdiction over the parties hereto in all
matters arising hereunder, and venue for such suit will be in a state or
federal court for the City of San Francisco,
California.
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15.10
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Attorney’s
Fees: The successful party in any litigation or other
dispute resolution proceeding to enforce the terms and conditions of this
Agreement shall be entitled to recover from the other party reasonable
attorney’s fees and related costs involved in connection with such
litigation or dispute resolution
proceeding.
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15.11
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Severability: In
the event that any term or provision of this Agreement shall violate any
applicable statute, ordinance, or rule of law in any jurisdiction in which
it is used, or otherwise be unenforceable, such provision shall be
ineffective to the extent of such violation without invalidating any other
provision hereof.
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15.11
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Headings,
Interpretation: The headings used in this Agreement are
for convenience only and are not part of this
Agreement.
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18
IN WITNESS WHEREOF, the
parties hereto have each caused this Drug Product Development and Clinical
Supply Agreement to be executed by their duly-authorized representatives as of
the Effective Date above written.
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BIO-PATH
HOLDINGS, INC.
By: /s/
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
Name: ▇▇▇▇▇
▇. ▇▇▇▇▇▇▇
Title: CEO
and President
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▇▇▇▇▇▇
TECHNOLOGIES, INC.
By: /s/
W. ▇▇▇▇ ▇▇▇▇▇
Name: W.
▇▇▇▇ ▇▇▇▇▇
Title: Executive
Vice President and CBO
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19