MASTER DEVELOPMENT AND MANUFACTURING AGREEMENT Clinical Products
Exhibit 10.1
Clinical Products
This Master Development and Manufacturing Agreement (this “Agreement”) is entered into
as of August 8, 2007, (the “Effective Date”) by and between Enzon Pharmaceuticals,
Inc., a Delaware corporation with an address of 000 Xxxxx 000-000, Xxxxxxxxxxx, Xxx Xxxxxx 00000
(“Enzon”), and Aradigm Corporation, a California corporation, having its principal place of
business at 0000 Xxxxx Xxxx Xxx, Xxxxxxx, XX 00000 (“Aradigm”). Enzon and Aradigm may be
referred to individually as a “Party” or collectively as “Parties.”
RECITALS
WHEREAS, Aradigm is engaged in the development and research of certain pharmaceutical products
and requires assistance in the technology transfer and manufacture of product;
WHEREAS, Enzon is a contract manufacturer that possesses the necessary technical capabilities
and operates facilities for the technology transfer and manufacture of pharmaceutical products;
WHEREAS, Aradigm desires Enzon to provide the Services specified in the Project Plans that may
be added to Appendix A by mutual agreement of the Parties; and
WHEREAS, Enzon is willing to provide the Services and fulfill the Project Plans on the terms
and conditions set forth below.
NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good
and valuable consideration, the receipt and adequacy of which each of the Parties does hereby
acknowledge, the Parties, intending to be legally bound, agree as follows:
Section 1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 “Applicable Laws” means all relevant federal, state and local laws,
statutes, rules, and regulations which are applicable to a Party’s activities hereunder, including,
without limitation, the applicable regulations and guidelines of any governmental authority
including the FDA and foreign counterparts and all applicable cGMPs together with amendments
thereto.
1.2 “cGMPs” shall mean current good manufacturing practices, including the
regulations promulgated by the FDA under the United States Food, Drug and Cosmetic Act, 21 C.F.R.
Part 210 et seq., as amended from time to time.
1.3 “Aradigm-supplied Materials” shall mean those materials supplied by
Aradigm for use in connection with the Services, which may include active pharmaceutical ingredient
and/or excipients.
1.4 “FDA” means the United States Food and Drug Administration or any
successor entity thereto.
1.5 “Product” means the finished product to be developed or manufactured by
Enzon pursuant to a Project Plan.
1.6 “Project Plan(s)” means a description of the Services to be provided and
related timeline and costs, pursuant to one or more project plans included in Appendix A
pursuant to Section 3.1.
1.7 “Process Consumables” means media, resins, raw materials, filters,
membranes, product contact materials or surfaces, disposable lab supplies and similar materials
used in the Project.
1.8 “Services” means, with respect to a Project Plan, those services
(including manufacture of Product) to be provided by Enzon described in the Project Plan executed
by the Parties and attached as Appendix A.
1.9 “Specifications” means the procedures, process parameters, analytical
tests and other attributes and written specifications for the Product attached hereto as part of a
Project Plan. Copies of such Specifications, as amended, shall be maintained by both Parties, and
shall become a part of this Agreement as if incorporated herein.
Section 2. ENGAGEMENT OF MANUFACTURER
Aradigm hereby engages Enzon to perform the Services in accordance with the terms and
conditions set forth herein, and Enzon hereby accepts such engagement. Enzon agrees to manufacture
and supply to Aradigm in accordance with the terms of this Agreement (including the applicable
Project Plan) the amount of the Product set forth on purchase orders submitted from time to time by
Aradigm under Section 3.5(a).
Section 3. PROJECT PLANS
3.1 Project Plans. With respect to a new project to be governed by this
Agreement (“Project”), a new Project Plan shall be added to Appendix A after execution by
the Parties of a written amendment in the form of the “Amendment to Appendix A”, attached hereto
(the “Amendment”). There shall be no limit to the number of Project Plans that may be
added to Appendix A and governed by the terms and conditions of this Agreement. In the
event of a conflict between the terms of a Project Plan and this Agreement, the terms of this
Agreement will govern.
3.2 Content of Project Plans. Each Project Plan shall include a description
of the Services to be provided, the Product to be manufactured, relevant specifications, forecasts
required herein, a schedule for completion of the Project Plan, a fee and payment schedule, and
such other information as is necessary for Enzon to perform the relevant Services.
3.3 Change Orders. In the event that Enzon is requested to perform services
that are outside the scope of agreed-upon Project Plans such changes must be mutually agreed upon
by the parties in a written change order prior to the provision of said services. Each such change
order constitutes an amendment to the applicable Project Plan (which shall be explicitly referenced
in such change order) and the services set forth therein shall be deemed to be Services part of
such Project Plan.
3.4 Project Management. With respect to each Project, each party will
appoint a project manager who will be the party responsible for overseeing the Project.
3.5 Forecasting and Aradigm-supplied Materials
(a) Unless specifically provided otherwise in a Project Plan, in connection with the
manufacture of Product, not less than ninety (90) days prior to the beginning of the manufacture of
a
Product under a Project Plan, Aradigm shall supply Enzon with a forecast showing Aradigm’s
estimated monthly requirements for Product(s) for the following twelve (12) month period.
Thereafter, on the first day of each calendar month, Aradigm shall deliver to Enzon an updated
forecast or Product requirements (in full-batch quantities) for the twelve (12) month period
commencing on the first day of the immediately following calendar month. The forecast for the
first six (6) calendar months of each forecast shall be binding on Aradigm and the forecast for the
final six (6) calendar months shall not be binding on Aradigm and shall be used by Enzon solely for
planning purposes. Product requirements for a particular month in the forecast shall not be
increased or decreased more than five percent (5%) from the prior forecast. Aradigm shall place
firm purchase orders for its requirement of the Product in full-batch quantities at least ninety
(90) days prior to the requested date of delivery. Each firm written purchase order, signed by
Aradigm’s duly authorized representative, shall authorize Enzon to manufacture such quantities of
the Product as are set forth therein. The number of purchase orders submitted by Aradigm shall not
exceed one (1) per calendar month, unless otherwise agreed to by the parties. Any purchase orders
for Product submitted by Aradigm shall be governed exclusively by the terms contained herein. Any
provision in any purchase order, invoice, or similar document furnished by Aradigm or Enzon that is
in any way inconsistent with the terms and conditions set forth in this Agreement is not valid
unless it is signed by both Parties.
(b) Unless specifically provided otherwise in a Project Plan, starting from
inception of the manufacture of a Product, Aradigm shall supply to Enzon, and ensure that Enzon
always has on hand, a safety stock of any Aradigm-supplied Materials that are to be supplied by
Aradigm not less than ten percent to twenty percent (10%-20%) above the quantity reasonably
needed (taking into consideration possible failed batches, wastage and yield variances) for the
next three (3) months of manufacture, as determined by the current forecast, or such greater
percentage as may be advisable with respect to long lead time materials. Enzon shall have no
obligation to supply Product if sufficient stock of Aradigm-supplied Materials have not been
supplied to it. In such case, manufacture may be delayed until receipt of adequate supplies of
Aradigm-supplied Materials and the availability of an appropriate manufacturing slot. Aradigm
shall be responsible for verifying that all Aradigm-supplied Materials meet relevant
specifications. Ownership of Aradigm-supplied Materials shall not be transferred to Enzon. In
case Aradigm-supplied Materials do not comply with the Specifications, Enzon shall promptly notify
Aradigm of such non-compliance and shall have the right to reject such Aradigm-supplied Materials.
Section 4. COMPENSATION
4.1 Generally. The fees and costs to be paid or reimbursed to Enzon in
connection with the Services shall be set forth in each Project Plan.
4.2 Invoicing and Payment. Unless specifically provided otherwise in a
Project Plan, all invoices and payments hereunder shall be in U.S. Dollars and shall be due and
payable thirty (30) days after the receipt of an invoice or date of delivery, whichever is earlier.
Payments will be made payable to Enzon at the address above. Late payments shall be subject to
interest assessed at the monthly rate of one and one-half percent (11/2%).
4.3 Taxes. All sales taxes, VAT, levies, surcharges or other similar
charges (but excluding any income taxes) and any penalties levied thereon which relate to any
amounts paid to Enzon hereunder shall be the responsibility of and paid by Aradigm.
4.4 Material Costs. Unless otherwise agreed upon, Enzon shall be
responsible for the procurement of all materials other than Aradigm-supplied Materials. Process
Consumables and any other Project-specific direct expenses set forth in the Project Plan will be
invoiced to Aradigm with a percentage xxxx-up to be set forth in the applicable Project Plan. The
cost of materials other than Process
Consumables and any other Project-specific direct expenses set forth in the Project Plan shall
be included as part of the budgeted fees in each Project Plan.
Section 5. CERTAIN REPRESENTATIONS, WARRANTIES, AND COVENANTS
OF ENZON:
5.1 Authority. Enzon represents and warrants that it has full authority to
enter into this Agreement.
5.2 Material/Supplies. Enzon shall use Aradigm-supplied Materials only in
accordance with the applicable Project Plan and Project and not for any other purpose.
5.3 Books and Records. Enzon shall maintain true and accurate books,
records, test and laboratory data, reports and all other information relating to Services performed
under this Agreement, including all information required to be maintained by Applicable Laws.
5.4 Regulatory Inspections. Enzon shall make its facilities and all records
relating to the Services available to the FDA or other regulatory authorities at times agreed with
such authorities and shall notify Aradigm if the FDA or other regulatory authority begins or
schedules an inspection of Enzon’s records, facilities, or manufacturing processes related to the
Services and provide Aradigm access to any documentation related to or resulting from the
inspection.
5.5 Debarment. Enzon hereby certifies it does not and shall not employ,
contract with or retain any person directly or indirectly to perform Services under this Agreement
if such person is debarred under 21 U.S.C. 335a (a) or (b) or other equivalent laws, rules,
regulations or standards of any other relevant jurisdiction.
5.6 Regulatory Filings. Enzon will cooperate in providing to Aradigm any
nonconfidential information in its control relating to this Agreement that Aradigm may reasonably
require in connection with its regulatory or governmental filings, provided that such information
shall be provided in whatever form held by Enzon. If applicable, Enzon will provide a letter
permitting FDA to reference its relevant drug master file.
5.7 Audits. Once each calendar year during the term of this Agreement,
Aradigm and its agents and designees shall have the right to audit Enzon’s facilities, systems, and
records solely related to this Agreement. Such audits may be conducted upon reasonable notice
during the term of this Agreement, so long as (i) all auditors have entered into confidentiality
agreements relating to the materials to be reviewed, (ii) no materials are removed from the
premises of Enzon, and (iii) a copy of all findings is provided to Enzon.
5.8 Product. Except with respect to Product that is produced as part of
development work (i.e., Product that is not intended for commercial distribution or for cGMP
stability or clinical studies), all Product delivered hereunder shall, in all material respects at
the time of delivery, conform with Specifications applicable to the relevant Product, and
have been manufactured in accordance with Applicable Law.
OF ARADIGM:
5.9 Authority. Aradigm represents and warrants that it has full authority
to enter into this Agreement.
5.10 Aradigm-supplied Materials. Aradigm represents, warrants and covenants
as follows: (i) all Aradigm-supplied Materials will be supplied in a timely manner so as to enable
Enzon to complete the Services; (ii) all Aradigm-supplied Materials shall, in all material respects
at the time of delivery, be free from defect and shall meet all relevant specifications, (iii)
Aradigm shall take sole and exclusive responsibility for the quality and supply of all such
Aradigm-supplied Materials, including responsibility for all testing and inspection of the same,
and (iv) Enzon shall have no liability for Aradigm-supplied Materials except to the extent caused
solely by its gross negligence or willful misconduct.
Section 6. ADDITIONAL PRODUCT SUPPLY TERMS
6.1 Delivery. Delivery terms shall be EXW (Incoterms 2000) Enzon’s
manufacturing facility in Indianapolis, Indiana. Enzon shall assume no risk or responsibility for
Product after delivery in accordance with this provision. Enzon shall use commercially reasonable
efforts to meet the requested delivery dates set forth in Aradigm’s purchase orders.
6.2 Rejected Goods; Failure of Supply.
(a) Promptly following receipt of Product, Aradigm shall have the right but not the
obligation to test such Product to determine compliance with the warranties set forth in Section
5.8. Aradigm shall notify Enzon in writing of any rejection of Product based on any claim that the
Product fails to meet the warranties in Section 5.8 within thirty (30) days of delivery, after
which point all unrejected Product shall be deemed accepted.
(b) In the event that Enzon believes that Product has been incorrectly rejected,
Enzon may require that Aradigm provide to it Product samples for testing. Enzon may retain and
test the samples of Product retained by it. In the event of a discrepancy between Aradigm’s and
Enzon’s test results such that one Party’s test results fall within relevant Specifications and the
other Party’s test results fall outside the relevant Specifications, or there exists a dispute
between the Parties over the extent to which such failure is attributable to a given Party, the
Parties shall cause an independent laboratory or appropriate expert promptly to review records,
test data and perform comparative tests and/or analyses on samples of the alleged defective
Product. Such independent laboratory or expert shall be mutually agreed upon by the Parties. The
independent laboratory’s results shall be in writing and shall be final and binding save for
manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with
such testing and review shall be borne by the Party against whom the independent laboratory rules.
(c) Enzon shall replace any rightly rejected Product as promptly as practicable, in
light of available manufacturing capacity, after the notice of such rejection, and in any case as
soon as reasonably possible after receiving such notice, provided that Aradigm shall provide to
Enzon sufficient quantities of Aradigm-supplied Materials at no additional cost to Enzon.
(d) If Enzon fails to deliver to Aradigm on a timely basis the full amount of
Product, meeting all Specifications and other requirements of this Agreement, under any Aradigm
purchase order submitted under Section 3.5(a), Enzon shall use its reasonable best efforts to cure
such failure. Further, if Enzon should perceive that a shortfall in delivery of Product by Enzon
is likely to occur for any reason, Enzon shall notify Aradigm as soon as practicable, and the
Parties shall discuss appropriate steps to alleviate such a shortfall.
(e) Withdrawal; Modification; Complaints. Subject to this remainder of this
Section 6.2 and to Section 11.2, Aradigm shall be responsible for the cost of and all losses
associated with any product withdrawal or modification involving the Product. Enzon
shall
reasonably cooperate with Aradigm in connection with any withdrawal, or modification, at the
expense of Aradigm. Aradigm shall share with Enzon all relevant information relating to any such
withdrawal, or modification. In addition, Aradigm shall also promptly and fully detail for Enzon
any Product complaints it receives.
Section 7. TERM AND TERMINATION
7.1 Term. This Agreement shall commence on the Effective Date and shall
extend for a period of five (5) years unless terminated earlier as provided herein or extended by
mutual written consent of the Parties. Notwithstanding the foregoing, each Project Plan under
Appendix A may have separate term and termination provisions so long as the term of any
Project Plan does not extend beyond the term of this Agreement.
7.2 Termination. This Agreement or any Project Plan may be terminated:
(a) by either Party if the other Party breaches a material provision of this
Agreement or a Project Plan and fails to cure such breach to the reasonable satisfaction of the
non-breaching Party within sixty (60) days (fifteen (15) days for nonpayment) following written
notification of such breach from the non-breaching party to the breaching party;
(b) by either Party, immediately, if the other Party becomes insolvent, is dissolved
or liquidated, makes a general assignment for the benefit of its creditors, or files or has filed
against it, a petition in bankruptcy or has a receiver appointed for a substantial part of its
assets and the appointment continues without discharge or stay for sixty (60) days; or
(c) by a Party or the Parties pursuant to Section 13.
7.3 In the event of termination hereunder, Enzon shall be compensated for Services
properly rendered up to the date of termination, including in respect to any Product
in-process, and all costs incurred through the date of termination, including for materials used or
purchased for use in the Project. In addition, in the event of termination by Aradigm pursuant to
Section 7.2(a) or by Enzon pursuant to 7.2(b), Aradigm shall pay Enzon, as liquidated damages and
not as a penalty, a cancellation fee equal to a percentage, as set forth in the Project Plans, of
the uninvoiced portion of the total Project budget, as set forth in the Project Plans, as of the
effective date of the termination.
7.4 Survival. The rights and obligations of each Party which by their
nature survive the termination or expiration of this Agreement shall survive the termination or
expiration of this Agreement, including Sections 4-6, 7.3, 7.4, 8, 9, 10, 11, 14, and 15 (to the
extent relevant). In addition, Enzon hereby acknowledges that neither expiration nor termination
of this Agreement shall affect in any manner Aradigm’s right to manufacture and sell or have
manufactured and sold, the Product.
Section 8. INTELLECTUAL PROPERTY
8.1 Aradigm Intellectual Property. All inventions (whether patentable or
not), discoveries, improvements, data, information, reports and any and all related documentation,
which were or are made, conceived or developed, directly or indirectly by Aradigm prior to or after
the Effective Date (“Aradigm Background IP”) shall remain the sole property of Aradigm.
8.2 Enzon Intellectual Property. All inventions (whether patentable or
not), discoveries, improvements, data, information, reports and any and all related documentation,
which were or are made, conceived or developed, directly or indirectly by Enzon prior to or after
the Effective Date (“Enzon Background IP”) shall remain the sole property of Enzon.
8.3 Developed IP. Enzon agrees and acknowledges that Aradigm shall own all
right, title, and interest in and to all inventions, technology, discoveries, or ideas conceived,
reduced to practice, made, or developed by Enzon or its agents in the performance of a Project and
all intellectual property rights arising therefrom (the “Developed IP”). Enzon hereby assigns and
transfers to Aradigm all right, title and interest in and to such Developed IP and agrees to take
all further acts reasonably required to evidence such assignment and transfer to Aradigm at
Aradigm’s expense. Enzon shall enter into an agreement with each employee or agent of Enzon
performing work in connection with the Services, pursuant to which such person shall grant all
rights in the Developed IP to Enzon such that Enzon may assign and transfer such rights to Customer
in accordance with this Section 8.3. All Developed IP and any information with respect thereto
shall be treated under this Agreement as the confidential information of Aradigm. All tangible
property provided to Enzon in connection with this Agreement shall be and remain the exclusive
property of Aradigm. Aradigm shall own all right, title, and interest in and to any deliverables
provided by Enzon hereunder, and any intermediate or finished products generated by Enzon as a
result of conducting a Project. Such deliverables and products, and any information with respect
thereto, shall be treated under this Agreement as the confidential information of Aradigm.
Notwithstanding anything herein to the contrary, Enzon shall own all rights to any invention
(whether or not patentable) relating to manufacturing and analytical methods and processes
developed by Enzon in connection with services performed hereunder that have general use in
biopharmaceutical manufacturing, to the extent not specific to Aradigm’s products, and any
pre-existing know-how (“Process Invention”). Enzon reserves the right to use data developed
during the course of performing services hereunder to support applications, assignments or other
instruments necessary to apply for and obtain patent or other intellectual property protection
with respect to Process Inventions so long as no information which Enzon is required to keep
confidential under this Agreement is disclosed in any such application, assignment, or other
instrument without the prior consent of Aradigm (not to be unreasonably withheld). For Process
Inventions developed by Enzon in connection with performing services hereunder, Enzon will grant
to Aradigm a perpetual, world-wide, royalty-free, non-exclusive license for Aradigm to use such
Process Inventions in the development and manufacture of Aradigm’s products.
8.4 Disclosure and Assignment. With respect to all Developed IP, (i) Enzon
agrees to disclose the same promptly to Aradigm; (ii) Enzon agrees to execute documents evidencing
the rights set forth in this Section; and (iii) Enzon agrees to assist and cooperate with Aradigm
in applying for, letters patent or like corresponding legal protection of any of the foregoing in
the United States and all foreign countries (and for any extension, continuation, validation,
reissue or renewal thereof). For that purpose, Enzon agrees to execute all papers necessary
therefor, including assignments, without consideration, and also agree without further
consideration, but at Aradigm’s expense, to provide such information as may be reasonably required
in the preparation and prosecution of any patent application, the enforcement of any such resulting
patent, or the protection of any such invention or discovery.
Section 9. CONFIDENTIALITY
9.1 Confidential Information. Subject to Section 9.2, the Parties agree to
treat all Confidential Information as being secret and confidential and shall use it only as
permitted under this Agreement. For the purposes of this Agreement, “Confidential
Information” of a Party shall mean information acquired by the other Party from such Party and
identified as being confidential (except that Developed IP andProcess Inventions shall be treated
as set forth in the remainder of this Section 9.1). Aradigm’s Confidential Information includes,
but is not limited to, Aradigm Background IP and the
Developed IP owned by Aradigm, confidential information provided to Enzon prior to the date
hereof, all proprietary information regarding any Product, its raw materials, processes, know-how,
formulations, analytical procedures, clinical procedures, its other regulatory filings, and other
information related to any Product that may or will be under development. Enzon’s Confidential
Information includes, but is not limited to, Enzon Background IP and the Process Inventions owned
by Enzon and all information regarding its business, manufacturing procedures and processes,
know-how, customers, and price lists. As used in this Article 10, with respect to a particular
Party’s Confidential, such Party is the “Disclosing Party” and the other Party is the
“Recipient”.
9.2 Exceptions. The provisions of Section 9.1 shall not apply to any
information disclosed hereunder that:
(a) was lawfully known to the Recipient prior to its date of disclosure by the
Disclosing Party as evidenced by the Recipient’s written records;
(b) is disclosed lawfully to Recipient either before or after the date of the
disclosure by the Disclosing Party, without an obligation of confidentiality by sources (other than
the Disclosing Party) rightfully in possession of the Confidential Information;
(c) is published or generally known to the public, either before or after the date
of disclosure through no fault or omission on the part of the Recipient;
(d) is independently developed by the Recipient without reference to or in reliance
upon the Confidential Information; and
In addition, Section 9.1 shall not prevent Recipient from making any disclosures that are required
by Applicable Laws, to defend or prosecute litigation or to comply with governmental regulations,
provided that the Recipient provides prior written notice of such disclosure to the Disclosing
Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such
disclosure.
9.3 Survival. The obligations of confidentiality set forth in this
Agreement shall survive its termination or expiration for a period of five (5) years.
Section 10. INSURANCE
Each Party shall for the term of this Agreement and for five (5) years after the last Product
is delivered, obtain and maintain at its own cost and expense from a qualified insurance company,
comprehensive general liability insurance including, but not limited to, contractual liability
coverage and standard product liability coverage in an amount commensurate with industry standards.
At a Party’s request, the other Party shall provide it with proof of such coverage.
Section 11. INDEMNIFICATION AND LIMITS OF LIABILITY
11.1 Enzon Indemnity. Aradigm agrees to indemnify, defend and hold harmless
Enzon (and its directors, officers, employees, and agents) from and against damages finally awarded
or finally paid in settlement of any and all losses (including attorney fees and expenses) arising
as a result of third party claims (“Losses”) arising out of or in connection with (i)
injuries and/or death to humans resulting from the Product, (ii) Aradigm’s advertising, labeling,
or improper handling and storage of Product, (iii) any gross negligence, willful misconduct or
misrepresentation by Aradigm or material breach by Aradigm of this Agreement, or (iv) any
manufacture, use or sale of the product infringes the intellectual property rights or other rights
of a third party, or (v) any defect, insufficient supply of or delay in supply of
Aradigm-supplied Materials, except to the extent that such Losses are attributable to the
negligence or willful misconduct of or breach of this Agreement by Enzon or Enzon’s employees or
agents.
11.2 Aradigm Indemnity. Subject to Section 11.3, Enzon shall indemnify,
defend and hold harmless Aradigm (and its directors, officers, employees, and agents) from
and against Losses arising out of or in connection with: (i) with respect to Product, any Product
that does not meet the warranty set forth in Section 5.8, and (ii) any gross negligence, willful
misconduct or misrepresentation by Enzon or material breach by Enzon of this Agreement, except to
the extent that such Losses are attributable to the negligence or willful misconduct of or breach
of this Agreement by Aradigm or Aradigm’s employees or agents.
11.3 LIMITS ON LIABILITY/EXCLUSIVE WARRANTY AND REMEDY. IN NO EVENT SHALL
ENZON BE LIABLE TO ARADIGM WITH RESPECT TO ARADIGM-SUPPLIED MATERIALS FOR AN AGGREGATE AMOUNT IN
EXCESS OF FIVE THOUSAND ($5,000). ENZON SHALL NOT BE LIABLE TO ARADIGM FOR ANY AMOUNTS WHICH IN
THE AGGREGATE EXCEED THE TOTAL VALUE OF MONIES PAID TO ENZON HEREUNDER. NEITHER PARTY SHALL IN ANY
EVENT BE LIABLE TO THE OTHER PARTY UNDER THIS AGREEMENT FOR ANY INDIRECT, CONSEQUENTIAL, PUNITIVE,
EXEMPLARY, SPECIAL DAMAGES, LOST PROFITS, OR LOST REVENUES. NEITHER PARTY MAKES ANY WARRANTIES
HEREUNDER, INCLUDING ANY WARRANTIES (EXPRESS OR IMPLIED) WITH RESPECT TO PERFORMANCE,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THIRD-PARTY INTELLECTUAL
PROPERTY, EXCEPT TO THE EXTENT SPECIFICALLY SET FORTH IN ARTICLE 5 HEREOF. NOTWITHSTANDING
ANYTHING TO THE CONTRARY HEREIN, ARADIGM’S SOLE AND EXCLUSIVE REMEDY FOR PRODUCT THAT DOES NOT MEET
THE WARRANTY SET FORTH IN SECTION 5.8 SHALL BE REPLACEMENT OF THE PRODUCT TO THE EXTENT PERMITTED
UNDER SECTION 6.2
Section 12. PUBLICITY AND PUBLICATIONS
Neither Aradigm nor Enzon shall make any news release or other public statement, whether to
the press or otherwise, disclosing the existence of this Agreement, the terms thereof or of any
amendment thereto or any Project Plan without the prior written approval of the other Party, except
as required by law or regulation and if so required, only after giving reasonable notice
and time to review and comment to the extent practicable; provided, that, in such comments, such
other Party may not object to references to its name in such required disclosures.
Section 13. FORCE MAJEURE
If either Party (the “Affected Party”) shall be delayed or hindered in or prevented from the
performance of any act required hereunder by reason of strike, lockouts, labor troubles,
restrictive governmental or judicial orders or decrees, riots, insurrection, war, terrorist acts,
acts of God, inclement weather or other reason or cause reasonably beyond such Party’s control
(each a “Force Majeure”), then performance of such act shall be excused for the period of such
Force Majeure. The Party affected by the Force Majeure shall provide notice to the other Party
(the “Non-Affected Party”) of the commencement and termination of the Force Majeure. Should a
Force Majeure continue for more than three (3) months, the Non-Affected Party may terminate this
Agreement upon prior written notice to the Affected Party.
Section 14. NOTICES
All notices or other communications that are required or permitted by this Agreement shall be
in writing and shall be delivered personally, sent by fax (and promptly confirmed by overnight
courier), sent
by nationally recognized overnight courier or sent by registered or certified mail, postage
prepaid, return receipt requested, addressed as follows:
If to Aradigm:
|
Aradigm Corporation | |
| 0000 Xxxxx Xxxx Xxx | ||
| Xxxxxxx, Xxxxxxxxxx 00000 | ||
| Attn: Xxxxxx Xxxxxxxxx | ||
| Facsimile No.: 000-000-0000 | ||
with a copy to:
|
Aradigm Corporation | |
| 0000 Xxxxx Xxxx Xxx | ||
| Xxxxxxx, Xxxxxxxxxx 00000 | ||
| Attn: General Counsel | ||
| Facsimile No.: 510.265.5035 | ||
If to Enzon:
|
Enzon Pharmaceuticals, Inc. | |
| 000 Xxxxx 000/000 | ||
| Xxxxxxxxxxx, Xxx Xxxxxx 00000 | ||
| Facsimile 000-000-0000 | ||
| Attention: Executive Vice President, Technical Operations | ||
with a copy to:
|
Enzon Pharmaceuticals, Inc. | |
| 000 Xxxxx 000-000 | ||
| Xxxxxxxxxxx, Xxx Xxxxxx 00000 | ||
| Facsimile: 000-000-0000 | ||
| Attention: General Counsel |
All notices delivered pursuant to this Section shall be considered delivered upon receipt by the
intended recipient.
Section 15. MISCELLANEOUS
15.1 Amendments; Assignment. This Agreement, including any Project Plans or
other attachments, may not be altered, amended or modified except by a written document signed by
both Parties. Neither party may assign this Agreement without the prior written consent of the
other party and any purported assignment in contravention of this Section shall be null and void;
provided, however, that either party may assign this Agreement in connection with the sale of all
or substantially all of its assets related to this Agreement.
15.2 Subcontracting. Enzon may not subcontract or delegate any of its rights
or obligations under this Agreement without the express prior written authorization of Aradigm. In
the event that Aradigm authorizes Enzon’s use of a subcontractor, Enzon shall cause any such
subcontractor to be subject by contract to the same restrictions, exceptions, obligations, reports,
termination provisions and other provisions contained in this Agreement or any applicable Project
Plan.
15.3 Successors; Assigns. This Agreement shall be binding upon and inure to
the benefit of the Parties hereto and each of their respective successors and permitted assigns.
15.4 Severability. All agreements and covenants contained herein are
severable, and in the event any of them shall be held to be invalid by any competent court, this
Agreement shall be interpreted as if such invalid agreements or covenants were not contained
herein. Entire Agreement. This Agreement,
including the attached Project Plans, constitutes the entire agreement between the Parties
with respect to the subject matter of this Agreement and supersedes all prior
communications, representations, or agreements, either verbal or written between the Parties with
respect to such subject matter. Each Party confirms that it is not relying on any representations
or warranties of the other Party except as specifically set forth herein.
15.5 Independent Contractor. This Agreement shall not be deemed to create
any partnership, joint venture, or agency relationship between the Parties. Each Party shall act
hereunder as an independent contractor and its agents and employees shall have no right or
authority under this Agreement to assume or create any obligation on behalf of, or in the name of,
the other Party. All persons employed by a Party shall be employees of such Party and not of the
other Party, and all costs and obligations incurred by reason of any such employment shall be for
the account and expense of such Party.
15.6 Waiver. The waiver by either Party of any right hereunder shall not be
deemed a waiver of any other right hereunder.
15.7 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
15.8 Headings. The headings used in this Agreement are for convenience only
and are not a part of this Agreement.
15.9 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of New Jersey, without application of its principles of
conflict of laws.
* * * * *
IN WITNESS WHEREOF, each of the Parties hereto has caused this Master Development and
Manufacturing Agreement to be executed by its duly authorized representative as of the date written
above.
| ENZON PHARMACEUTICALS, INC. |
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| By: | ||||
| Name | ||||
| Title |
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| [ARADIGM] |
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| By: | ||||
| Name | ||||
| Title | ||||
APPENDIX A
Project
Plan A-1
Project Plan A-2
[Attached]
Project Plan A — 1
Aradigm Corporation
Liposomal Ciprofloxacin for Inhalation
Liposomal Ciprofloxacin for Inhalation
This is a Project Plan in accordance with the Master Development and Manufacturing Agreement,
effective August 8, 2007,
(“Agreement”) between Enzon and Aradigm. All capitalized terms not defined herein
shall have the meaning ascribed to them in the Agreement.
| 1. | Enzon agrees to provide to Aradigm the services related to Liposomal Ciprofloxacin for Inhalation as described in the work plan and specific terms set forth in greater detail on Quote # 7-001 Rev 2a (“Quote”). The Quote shall be signed by both parties. | ||
| 2. | The aggregate costs and fees are $ 2,831,500.00, plus the costs and fees for Stability Studies, as well as other costs and fees set forth in the Quote, to be paid in accordance with the payment schedule and specific payment terms set forth in the Quote. | ||
| 3. | The effective date of this Project Plan is August 8, 2007. This Project Plan shall continue in force for the period of time provided in the Quote. | ||
| 4. | The parties agree that this Project Plan is governed by and subject to the terms and conditions on the Agreement between the parties which shall apply to this Project Plan as if said terms and conditions were fully set forth herein. |
IN WITNESS WHEREOF, each of the Parties hereto has caused this Project Plan to be executed by its
duly authorized representative as of the date written above.
| ENZON PHARMACEUTICALS, INC. |
||||
| By: | ||||
| Name | ||||
| Title | ||||
| [ARADIGM CORPORATION] |
||||
| By: | ||||
| Name | ||||
| Title | ||||
Project Plan A — 2
Aradigm Corporation
Ciprofloxacin for Inhalation
Ciprofloxacin for Inhalation
This is a Project Plan in accordance with the Master Development and Manufacturing Agreement,
effective August 8, 2007,
(“Agreement”) between Enzon and Aradigm. All capitalized terms not defined herein
shall have the meaning ascribed to them in the Agreement.
| 5. | Enzon agrees to provide to Aradigm the services related to Liposomal Ciprofloxacin for Inhalation as described in the work plan and specific terms set forth in greater detail on Quote # 7-002 Rev 2a (“Quote”). The Quote shall be signed by both parties. | ||
| 6. | The aggregate costs and fees are $463,000.00 plus other costs and fees set forth in the Quote, to be paid in accordance with the payment schedule and specific payment terms set forth in the Quote. | ||
| 7. | The effective date of this Project Plan is August 8, 2007. This Project Plan shall continue in force for the period of time provided in the Quote. | ||
| 8. | The parties agree that this Project Plan is governed by and subject to the terms and conditions on the Agreement between the parties which shall apply to this Project Plan as if said terms and conditions were fully set forth herein. |
IN WITNESS WHEREOF, each of the Parties hereto has caused this Project Plan to be executed by its
duly authorized representative as of the date written above.
| ENZON PHARMACEUTICALS, INC. |
||||
| By: | ||||
| Name | ||||
| Title | ||||
| [ARADIGM CORPORATION] |
||||
| By: | ||||
| Name | ||||
| Title | ||||
