Preview
Full Doc
 | 2001 |
Process Development and Manufacturing Agreement
Process Development and Manufacturing Agreement (156K)
Doc #322525: Click preview link for longer preview.
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
BETWEEN
XOMA (US) LLC
AND
ONYX PHARMACEUTICALS, INC.
JANUARY 29, 2001
{PAGE}
TABLE OF CONTENTS
{TABLE}
{CAPTION}
PAGE
{S} {C}
1. DEFINITIONS..............................................................................1
1.1 "Acceptance Period".............................................................1
1.2 "Affiliate".....................................................................1
1.3 "Attainment of Commercial Scale"................................................1
1.4 "Batch".........................................................................2
1.5 "BLA"...........................................................................2
1.6 "cGMP"..........................................................................2
1.7 "Commercial Scale"..............................................................2
1.8 "Confidential Information"......................................................2
1.9 "Control", "Controls" and "Controlled"..........................................2
1.10 "Delivery Date".................................................................2
1.11 "Development Phase".............................................................2
1.12 "Development Scale".............................................................2
1.13 "Drug Substance"................................................................2
1.14 "Facility"......................................................................2
1.15 "FDA"...........................................................................2
1.16 "FD&C Act"......................................................................2
1.17 "Fully Burdened Staffing Costs".................................................2
1.18 "IND"...........................................................................3
1.19 "Intellectual Property Rights"..................................................3
1.20 "Innovations"...................................................................3
1.21 "Letter Agreement"..............................................................3
1.22 "Manufacturing Phase"...........................................................3
1.23 "ONYX-015"......................................................................3
1.24 "ONYX-015 Derivative"...........................................................3
1.25 "Onyx Innovations"..............................................................3
1.26 "Onyx Partner"..................................................................3
1.27 "Party" and "Parties"...........................................................3
1.28 "Patents".......................................................................3
1.29 "Project".......................................................................3
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
i.
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
{TABLE}
{S} {C}
1.30 "Project Innovations"...........................................................3
1.31 "Project Team"..................................................................3
1.32 "Regulatory Approval"...........................................................3
1.33 "Regulatory Authority"..........................................................4
1.34 "Shelf Life"....................................................................4
1.35 "Specifications"................................................................4
1.36 "Suite".........................................................................4
1.37 "Third Party"...................................................................4
1.38 "Work Plan".....................................................................4
1.39 "XOMA Innovations"..............................................................4
1.40 "Yield".........................................................................4
2. OVERVIEW AND GOVERNANCE OF MANUFACTURING RELATIONSHIP....................................4
2.1 Project; Committed Resources; Schedule..........................................4
2.2 Work Plan.......................................................................5
2.3 Project Team....................................................................5
2.4 Senior Management Oversight and Dispute Resolution..............................6
2.5 Specifications; Changes to Specifications and Work Plan.........................6
2.6 Onyx Representatives............................................................7
2.7 Non-Exclusive Relationship......................................................7
2.8 Non-Solicitation and Non-Hire Obligations.......................................7
2.9 Compliance with Laws............................................................7
3. FACILITIES AND EQUIPMENT.................................................................7
3.1 Dedicated Manufacturing Suite...................................................7
3.2 Additional Equipment and Facility Modifications.................................8
(a) Development Phase Equipment Purchases..................................8
(b) Manufacturing Phase Equipment Purchases................................8
(c) Suite Modifications....................................................8
3.3 Replacement Suite...............................................................8
3.4 Compliance Audit................................................................9
4. TECHNOLOGY TRANSFER, SCALE-UP, PURIFICATION AND PROCESS DEVELOPMENT......................9
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
ii.
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
{TABLE}
{S} {C}
4.1 Manufacturing Technology Transfer to XOMA.......................................9
4.2 Scale-up of Manufacture.........................................................9
(a) Establishment of Commercial Scale......................................9
(b) Additional Registration Batches........................................9
(c) Non-Attainment of [ * ]L Scale........................................10
4.3 Production at Development Scale................................................10
5. CLINICAL AND COMMERCIAL SUPPLY; REGULATORY MATTERS......................................10
5.1 Raw Materials Services; In-Process Testing.....................................10
5.2 Minimum Batch Manufacture......................................................11
(a) First Year............................................................11
(b) Subsequent Years......................................................11
(c) Additional Batches....................................................11
(d) Reductions in Minimum Batch Commitments...............................11
(e) Increases in Capacity for Drug Substance Manufacture..................11
5.3 Orders and Supply..............................................................12
(a) General...............................................................12
(b) Purchase Orders.......................................................12
(c) Cancellations.........................................................12
(d) Rescheduling..........................................................12
5.4 Commercial Supply Forecast.....................................................12
5.5 Delivery.......................................................................12
5.6 Testing, Acceptance and Rejection..............................................13
5.7 Regulatory Changes.............................................................14
5.8 Change in Manufacturing Process................................................14
5.9 Samples........................................................................14
5.10 Regulatory Matters.............................................................14
6. PRICES AND PAYMENT......................................................................15
6.1 Upfront Payment................................................................15
6.2 Space Fee......................................................................15
6.3 Equipment and Facility Reimbursement...........................................15
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
iii.
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
{TABLE}
{S} {C}
6.4 Personnel Costs................................................................15
(a) Development Phase.....................................................15
(b) Manufacturing Phase...................................................15
(c) Regulatory Work.......................................................15
(d) Post-Termination or -Expiration Technology Transfer...................16
6.5 Milestone Payments.............................................................16
(a) Initial Commercial Scale Batch Meeting Specifications and
with Adequate Yield...................................................16
(b) Yield Improvements....................................................16
(c) Regulatory Approval for Facility......................................16
6.6 Commercial Scale Batch Payments................................................17
(a) Batch Price...........................................................17
(b) Additional Batches....................................................17
(c) Adjustments...........................................................17
(d) Additional Orders at Commercial Scale.................................17
6.7 Payment........................................................................17
6.8 Records........................................................................17
6.9 Taxes Withheld.................................................................18
7. TECHNOLOGY AND INFORMATION..............................................................18
7.1 Technology Transfer............................................................18
(a) Periodic Updates......................................................18
(b) Expiration, Termination or upon Request...............................18
7.2 Information....................................................................19
(a) Documentation.........................................................19
(b) Access................................................................19
(c) Audit of Records......................................................19
7.3 Licenses.......................................................................19
(a) Development and Manufacturing License to XOMA.........................19
(b) Project Innovations License to XOMA...................................19
(c) XOMA Innovations License to Onyx......................................19
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
iv.
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
{TABLE}
{S} {C}
7.4 Ownership of Innovations and Intellectual Property.............................20
(a) Third Party Technology................................................20
(b) Onyx Innovations......................................................20
(c) XOMA Innovations......................................................20
(d) Project Innovations...................................................20
7.5 Patenting of Project Innovations...............................................20
7.6 Infringement of Patents........................................................21
8. REPRESENTATIONS AND WARRANTIES; DISCLAIMERS.............................................22
8.1 Drug Substance Warranties and Remedy...........................................22
(a) Warranties............................................................22
(b) Remedy................................................................22
8.2 General Representations and Warranties.........................................22
(a) Corporate Existence and Power.........................................22
(b) Authority and Binding Agreement.......................................22
(c) Title.................................................................23
8.3 Warranty Disclaimer............................................................23
9. INDEMNIFICATION; LIMITATION OF LIABILITY................................................23
9.1 Onyx Indemnity.................................................................23
9.2 XOMA Indemnity.................................................................23
9.3 Separate Defenses..............................................................23
9.4 Expenses.......................................................................24
9.5 Limitation of Liability........................................................24
10. CONFIDENTIALITY.........................................................................24
10.1 Confidential Information; Exceptions...........................................24
10.2 Authorized Disclosure..........................................................25
10.3 Press Releases.................................................................26
10.4 Requests for Confidential Treatment............................................26
10.5 Return of Confidential Information.............................................26
10.6 Injunctive Relief..............................................................26
10.7 Survival.......................................................................26
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
v.
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
{TABLE}
{S} {C}
10.8 Superseding Effect.............................................................27
11. TERM AND TERMINATION....................................................................27
11.1 Term...........................................................................27
11.2 Termination by XOMA............................................................27
11.3 Termination by Onyx............................................................27
(a) Delay in Performance by XOMA..........................................27
(b) For Convenience Before Attainment of Commercial Scale.................28
(c) For Convenience After Attainment of Commercial Scale..................28
11.4 Breach.........................................................................29
11.5 Technology Transfer............................................................29
11.6 Surviving Obligations..........................................................29
12. MISCELLANEOUS...........................................................................29
12.1 Notice.........................................................................29
12.2 Use of Names...................................................................30
12.3 Formal Dispute Resolution......................................................30
(a) Arbitration...........................................................30
(b) Intellectual Property Disputes........................................31
12.4 Rights in Bankruptcy...........................................................31
12.5 Waiver.........................................................................32
12.6 Assignment; Binding Effect.....................................................32
12.7 Independent Parties............................................................32
12.8 Force Majeure..................................................................32
12.9 Severability...................................................................32
12.10 Governing Law..................................................................33
12.11 Entire Agreement; Modification.................................................33
12.12 Counterparts...................................................................33
EXHIBIT A SPECIFICATIONS................................................................A-1
EXHIBIT B SUITE.........................................................................B-1
EXHIBIT C PRESS RELEASES................................................................C-1
{/TABLE}
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
vi.
{PAGE}
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
THIS AGREEMENT (the "AGREEMENT") is made effective as of the 29th day
of January, 2001 ("EFFECTIVE Date"), by and between XOMA (US) LLC, a Delaware
limited liability company ("XOMA"), with offices at 2910 Seventh Street,
Berkeley, California 94710, USA, and ONYX PHARMACEUTICALS, INC., a Delaware
corporation ("ONYX"), with offices at 3031 Research Drive, Richmond, California
94806, USA. XOMA and Onyx are sometimes referred to herein individually as a
"PARTY" and collectively as "PARTIES".
RECITALS
WHEREAS, Onyx, a biotechnology company engaged in the discovery and
development of novel pharmaceuticals for cancer indications, has discovered and,
together with its collaboration partner, Pfizer Inc. ("PFIZER"), is developing a
novel replicating virus, ONYX-015 (also known as CI-1042 and further defined
below), as a biopharmaceutical product now in Phase III clinical trials.
Currently, ONYX-015 is manufactured at small scale by contract manufacturers;
WHEREAS, XOMA is a company that has developed substantial expertise in
process development, scale-up, and small- and large-scale manufacturing of its
own and its partners' biopharmaceutical products, and, in addition, has invested
in biopharmaceutical manufacturing facilities; and
WHEREAS, Onyx would like to engage XOMA to scale up and improve the
process for the manufacture of ONYX-015 and to manufacture and supply ONYX-015
in bulk form for clinical trials and for the commercial launch of the ONYX-015
product, and XOMA would like to provide such services to Onyx.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual promises and covenants set forth below, Onyx and XOMA mutually agree as
follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have the following
meanings:
1.1 "ACCEPTANCE PERIOD" shall have the meaning given such term in
Section 5.6(a).
1.2 "AFFILIATE" means any person or entity that, directly or
indirectly, through one or more intermediaries, Owns, is Owned by or is under
common Ownership with, a Party, where "Own", "Owned" or "Ownership" refers to
(a) direct or indirect possession of at least fifty percent (50%) of the
outstanding voting securities of a corporation or a comparable ownership in any
other type of entity; or (b) the actual ability of an entity, person or group to
control and direct the management of the person or entity, whether by contract
or otherwise.
1.3 "ATTAINMENT OF COMMERCIAL SCALE" shall have the meaning given
such term in Section 4.2(b).
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
1.
{PAGE}
1.4 "BATCH" means a specific quantity of Drug Substance that is
intended to have a uniform character and quality, within specified limits, and
that is produced according to a single manufacturing order during the same cycle
of manufacture.
1.5 "BLA" means a Biologics License Application filed with the FDA
or other equivalent application(s) for Regulatory Approval in a jurisdiction
other than the United States of America.
1.6 "CGMP" means the then current standards for manufacture of
biologicals, as set forth in the FD&C Act, and such standards of good
manufacturing practice as are required by the FDA or other Regulatory
Authorities with jurisdiction where ONYX-015 will be used in clinical trials or
commercialized.
1.7 "COMMERCIAL SCALE" means the [ * ]L nominal volume
fermentation bioreactor production scale for the ONYX-015 manufacturing process
that will result from scale-up work during the Development Phase, as it may be
modified pursuant to Section 4.2(c).
1.8 "CONFIDENTIAL INFORMATION" shall have the meaning given such
term in Section 10.1.
1.9 "CONTROL", "CONTROLS" and "CONTROLLED" mean, with respect to a
particular item of information or Intellectual Property Right, that the
applicable Party owns or has a license to such item or right and has the ability
to grant to the other Party access to and a license or sublicense (as
applicable) under such item or rights as provided for herein without violating
the terms of any agreement or other arrangement with any Third Party.
1.10 "DELIVERY DATE" shall have the meaning given such term in
Section 5.3(a).
1.11 "DEVELOPMENT PHASE" shall have the meaning given such term in
Section 2.2.
1.12 "DEVELOPMENT SCALE" means the [ * ]L, [ * ]L or comparable
nominal volume fermentation bioreactor production scales for the Drug Substance
manufacturing process transferred to XOMA and further developed under this
Agreement.
1.13 "DRUG SUBSTANCE" means a formulation of purified bulk ONYX-015
that has been manufactured and processed to the stage where it is suitable for
fill-and-finish procedures yielding the ONYX-015 product suitable for release
for use in clinical trials or commercial sales.
1.14 "FACILITY" shall have the meaning given such term in Section
3.1.
1.15 "FDA" means the United States Food and Drug Administration, or
any successor agency.
1.16 "FD&C ACT" means the United States Food, Drug and Cosmetics
Act and applicable regulations and guidances promulgated thereunder, as amended
from time to time.
1.17 "FULLY BURDENED STAFFING COSTS" shall have the meaning given
such term in Section 6.4(a).
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24-b2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
2.
{PAGE}
1.18 "IND" means an Investigational New Drug application as defined
in the FD&C Act and/or its equivalent in any country other than the United
States of America, the filing of which is necessary to commence clinical testing
of pharmaceutical products in humans.
1.19 "INTELLECTUAL PROPERTY RIGHTS" means patents, copyrights,
trademarks, service marks, trade secrets, mask works, and applications for the
foregoing, in any country, supranational organization or territory of the world.
1.20 "INNOVATIONS" means inventions, discoveries, works of
authorship, trade secrets and other know-how or developments.
1.21 "LETTER AGREEMENT" shall have the meaning given such term in
Section 2.1(a).
1.22 "MANUFACTURING PHASE" shall have the meaning given such term
in Section 2.2.
1.23 "ONYX-015" means the formulation of the genetically engineered
adenovirus DL1520 described in US Patent Numbers 5,677,178 and 5,846,945,
selected by ONYX, that is currently in Phase III clinical trials.
1.24 "ONYX-015 DERIVATIVE" means ONYX-015 derivatized by
engineering the ONYX-015 genome to contain one or more additional transgenes
that code for one or more protein(s).
1.25 "ONYX INNOVATIONS" shall have the meaning given such term in
Section 7.4(b).
1.26 "ONYX PARTNER" means any Third Party collaboration partner of
Onyx pursuant to a written agreement for the development and/or
commercialization of the ONYX-015 product, of which partner Onyx has given
written notice to XOMA. For clarity, Onyx's Third Party collaboration partner
for such purposes as of the Effective Date is Pfizer.
1.27 "PARTY" and "PARTIES" shall have the meanings given such
terms, respectively, in the first paragraph of this Agreement.
1.28 "PATENTS" means (i) United States issued patents,
re-examinations, reissues, renewals, extensions, patent term restorations, and
foreign counterparts of each of the foregoing; and (ii) pending applications for
United States patents and foreign counterparts thereof, whether issued or not.
322525
|
Citibank
As referenced in this Process Development and Manufacturing Agreement:
Citibank, N.A. – 30) days of receipt of the
invoice shall accrue interest at a rate equal to the lesser of prime rate as
posted by Citibank, N.A. , plus two percent (2%), or the highest interest rate
permitted under applicable law.
6.8 RECORDS. XOMA will keep accurate books and
_____________
dt 638646
;
Genentech
As referenced in this Process Development and Manufacturing Agreement:
Genentech, Inc – other protein biopharmaceuticals
for disease targets that include immunological and inflammatory disorders,
infectious diseases and cancer. Late-stage programs include a collaboration
with Genentech, Inc . to develop the anti-CD11a antibody product for psoriasis
(Phase III) and kidney transplant rejection (Phase I/II), and an agreement
with
_____________
Genentech, Inc – and other protein biopharmaceuticals
for disease targets that include immunological and inflammatory disorders,
infectious diseases and cancer. Late-stage programs include collaboration
with Genentech, Inc . to develop the anti-CD11a
[ * ]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH
_____________
dt 509462
;
Onyx Pharma
As referenced in this Process Development and Manufacturing Agreement:
ONYX PHARMACEUTICALS, INC – b2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
EXHIBIT 99.1
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
BETWEEN
XOMA (US) LLC
AND
ONYX PHARMACEUTICALS, INC .
JANUARY 29, 2001
{PAGE}
TABLE OF CONTENTS
{TABLE}
{CAPTION}
PAGE
{S} {C}
1. DEFINITIONS..............................................................................1
1.1 "Acceptance Period".............................................................1
1.2 "
_____________
ONYX PHARMACEUTICALS, INC – by and between XOMA (US) LLC, a Delaware
limited liability company ("XOMA"), with offices at 2910 Seventh Street,
Berkeley, California 94710, USA, and ONYX PHARMACEUTICALS, INC ., a Delaware
corporation ("ONYX"), with offices at 3031 Research Drive, Richmond, California
94806, USA. XOMA and Onyx are sometimes referred to herein
_____________
Onyx Pharmaceuticals, Inc – Department Attention: Geoffrey E. Liebmann, Esq.
Fax No.: (510) 649-7571 Fax No.: (212) 269-5420
If to Onyx: With a copy to:
Onyx Pharmaceuticals, Inc . Cooley Godward LLP
3031 Research Drive Five Palo Alto Square
Richmond, CA 94806 3000 El Camino Real
Attention: CEO Palo Alto, CA
_____________
ONYX PHARMACEUTICALS, INC – Party hereto has caused this Agreement to
be signed and delivered by its duly authorized officer or representative as
of the Effective Date.
ONYX PHARMACEUTICALS, INC . XOMA (US) LLC
By: /s/ HOLLINGS C. RENTON By: /s/ CLARENCE L. DELLIO
---------------------------- -------------------------------------
Name: Hollings C. Renton Name: Clarence L. Dellio
Title:
_____________
Onyx Pharmaceuticals, Inc – 3777
(310) 575-4848 www.lhai.com
{/TABLE}
ONYX AND XOMA ESTABLISH STRATEGIC PROCESS DEVELOPMENT AND MANUFACTURING
RELATIONSHIP
BERKELEY, CA -- JANUARY 29, 2001 - Onyx Pharmaceuticals, Inc . (Nasdaq: ONXX)
and XOMA Ltd. (Nasdaq: XOMA) today announced that they have agreed to a
strategic process development and manufacturing relationship under
_____________
dt 611630
;
|
Pfizer
As referenced in this Process Development and Manufacturing Agreement:
Pfizer Inc – a biotechnology company engaged in the discovery and
development of novel pharmaceuticals for cancer indications, has discovered and,
together with its collaboration partner, Pfizer Inc . ("PFIZER"), is developing a
novel replicating virus, ONYX-015 (also known as CI-1042 and further defined
below), as a biopharmaceutical product
_____________
Pfizer Inc – s CI-1042
(also known as ONYX-015), a therapeutic product to treat cancer. CI-1042,
which is being developed in collaboration with Pfizer Inc ., is currently in
Phase III testing for head and neck cancer.
The initial term of the agreement will be for five years,
_____________
Pfizer Inc – into a tumor cell, is the most commonly altered gene in
human cancer. CI-1042 is being jointly developed by Onyx Pharmaceuticals and
Pfizer Inc under an agreement signed in October 1999.
CI-1042, now in a Phase III clinical trial and various Phase I/II trials,
_____________
dt 611070
;
XOMA
As referenced in this Process Development and Manufacturing Agreement:
XOMA Ltd – com
{/TABLE}
ONYX AND XOMA ESTABLISH STRATEGIC PROCESS DEVELOPMENT AND MANUFACTURING
RELATIONSHIP
BERKELEY, CA -- JANUARY 29, 2001 - Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)
and XOMA Ltd . (Nasdaq: XOMA) today announced that they have agreed to a
strategic process development and manufacturing relationship under which XOMA
will scale-up
_____________
dt 505419
;
More... |
Preview
Full Doc
| 2001 |
Process Development and Manufacturing Agreement
Process Development and Manufacturing Agreement (138K)
Doc #329444: Click preview link for longer preview.
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
between
XOMA (US) LLC
and
ONYX PHARMACEUTICALS, INC.
January 29, 2001
{PAGE}
TABLE OF CONTENTS
PAGE
1. Definitions.........................................................1
1.1 "Acceptance Period"........................................1
1.2 "Affiliate"................................................1
1.3 "Attainment of Commercial Scale"...........................2
1.4 "Batch"....................................................2
1.5 "BLA"......................................................2
1.6 "cGMP".....................................................2
1.7 "Commercial Scale".........................................2
1.8 "Confidential Information".................................2
1.9 "Control", "Controls" and "Controlled".....................2
1.10 "Delivery Date"............................................2
1.11 "Development Phase"........................................3
1.12 "Development Scale"........................................3
1.13 "Drug Substance"...........................................3
1.14 "Facility".................................................3
1.15 "FDA"......................................................3
1.16 "FD&C Act".................................................3
1.17 "Fully Burdened Staffing Costs"............................3
1.18 "IND"......................................................3
1.19 "Intellectual Property Rights".............................3
1.20 "Innovations"..............................................3
-i-
{PAGE}
PAGE
1.21 "Letter Agreement".........................................4
1.22 "Manufacturing Phase"......................................4
1.23 "ONYX-015".................................................4
1.24 "ONYX-015 Derivative"......................................4
1.25 "Onyx Innovations".........................................4
1.26 "Onyx Partner".............................................4
1.27 "Party and Parties"........................................4
1.28 "Patents"..................................................4
1.29 "Project"..................................................4
1.30 "Project Innovations"......................................4
1.31 "Project Team".............................................4
1.32 "Regulatory Approval"......................................5
1.33 "Regulatory Authority".....................................5
1.34 "Shelf Life"...............................................5
1.35 "Specifications"...........................................5
1.36 "Suite"....................................................5
1.37 "Third Party"..............................................5
1.38 "Work Plan"................................................5
1.39 "XOMA Innovations".........................................5
1.40 "Yield"....................................................5
2. Overview and Governance of Manufacturing Relationship...............5
2.1 Project; Committee Resources; Schedule.....................5
-ii-
{PAGE}
PAGE
2.2 Work Plan..................................................7
2.3 Project Team...............................................7
2.4 Senior Management Oversight and Dispute Resolution.........7
2.5 Specifications; Changes to Specifications and Work Plan....8
2.6 Onyx Representatives.......................................8
2.7 Non-Exclusive Relationship.................................9
2.8 Non-Solicitation and Non-Hire Obligations..................9
2.9 Compliance with Laws.......................................9
3. Facilities and Equipment.............................................9
3.1 Dedicated Manufacturing Suite...............................9
3.2 Additional Equipment and Facility Modifications............10
(a) Development Phase Equipment Purchases..............10
(b) Manufacturing Phase Equipment Purchases............10
(c) Suite Modifications................................10
3.3 Replacement Suite..........................................11
3.4 Compliance Audit...........................................11
4. Technology Transfer, Scale-Up, Purification and Process Development.11
4.1 Manufacturing Technology Transfer to XOMA..................11
4.2 Scale-up of Manufacture....................................12
(a) Establishment of Commercial Scale..................12
(b) Additional Registration Batches....................12
(c) Non-Attainment of [*]L Scale.......................12
-iii-
{PAGE}
PAGE
4.3 Production at Development Scale............................13
5. Clinical and Commercial Supply; Regulatory Matters..................13
5.1 Raw Materials Services; In-Process Testing.................13
5.2 Minimum Batch Manufacture..................................14
(a) First Year.........................................14
(b) Subsequent Years...................................14
(c) Additional Batches.................................14
(d) Reductions in Minimum Batch Commitments............14
(e) Increases in Capacity for Drug Substance
Manufacture......................................15
5.3 Orders and Supply..........................................15
(a) General............................................15
(b) Purchase Orders....................................15
(c) Cancellations......................................15
(d) Rescheduling.......................................15
5.4 Commercial Supply Forecast.................................16
5.5 Delivery...................................................16
5.6 Testing, Acceptance and Rejection..........................16
5.7 Regulatory Changes.........................................17
5.8 Change in Manufacturing Process............................18
5.9 Samples....................................................18
5.10 Regulatory Matters.........................................18
-iv-
{PAGE}
PAGE
6. Prices and Payment..................................................18
6.1 Upfront Payment............................................18
6.2 Space Fee..................................................19
6.3 Equipment and Facility Reimbursement.......................19
6.4 Personnel Costs............................................19
(a) Development Phase..................................19
(b) Manufacturing Phase................................19
(c) Regulatory Work....................................19
(d) Post-Termination or -Expiration Technology
Transfer.........................................20
6.5 Milestone Payments.........................................20
(a) Initial Commercial Scale Batch Meeting
Specifications and with Adequate Yield...........20
(b) Yield Improvements.................................20
(c) Regulatory Approval for Facility...................21
6.6 Commercial Scale Batch Payments............................21
(a) Batch Price........................................21
(b) Additional Batches.................................21
(c) Adjustments........................................22
(d) Additional Orders at Commercial Scale..............22
6.7 Payment....................................................22
6.8 Records....................................................22
6.9 Taxes Withheld.............................................23
-v-
{PAGE}
PAGE
7. Technology and Information..........................................23
7.1 Technology Transfer........................................23
(a) Periodic Updates...................................23
(b) Expiration, Termination or Upon Request............23
7.2 Information................................................24
(a) Documentation......................................24
(b) Access.............................................24
(c) Audit of Records...................................24
7.3 Licenses...................................................24
(a) Development and Manufacturing License to XOMA......24
(b) Project Innovations License to XOMA................24
(c) XOMA Innovations License to Onyx...................25
7.4 Ownership of Innovations and Intellectual Property.........25
(a) Third Party Technology.............................25
(b) Onyx Innovations...................................25
(c) XOMA Innovations...................................25
(d) Project Innovations................................26
7.5 Patenting of Project Innovations...........................26
7.6 Infringement of Patents....................................27
8. Representations and Warranties; Disclaimers.........................27
8.1 Drug Substance Warranties and Remedy.......................27
(a) Warranties.........................................27
-vi-
{PAGE}
PAGE
(b) Remedy.............................................27
8.2 General Representations and Warranties.....................28
(a) Corporate Existence and Power......................28
(b) Authority and Binding Agreement....................28
(c) Title..............................................28
8.3 Warranty Disclaimer........................................28
9. Indemnification; Limitation of Liability............................29
9.1 Onyx Indemnity.............................................29
9.2 XOMA Indemnity.............................................29
9.3 Separate Defenses..........................................29
9.4 Expenses...................................................30
9.5 Limitation of Liability....................................30
10. Confidentiality.....................................................30
10.1 Confidential Information; Exceptions.......................30
10.2 Authorized Disclosure......................................32
10.3 Press Releases.............................................32
10.4 Requests for Confidential Treatment........................32
10.5 Return of Confidential Information.........................33
10.6 Injunctive Relief..........................................33
10.7 Survival...................................................33
10.8 Superseding Effect.........................................33
-vii-
{PAGE}
PAGE
11. Term and Termination................................................33
11.1 Term.......................................................33
11.2 Termination by XOMA........................................34
11.3 Termination by Onyx........................................34
(a) Delay in Performance by XOMA.......................34
(b) For Convenience Before Attainment of
Commercial Scale.................................35
(c) For Convenience After Attainment of
Commercial Scale.................................35
11.4 Breach.....................................................36
11.5 Technology Transfer........................................36
11.6 Surviving Obligations......................................37
12. Miscellaneous.......................................................37
12.1 Notice.....................................................37
12.2 Use of Names...............................................38
12.3 Formal Dispute Resolution..................................38
(a) Arbitration........................................38
(b) Intellectual Property Disputes.....................40
12.4 Rights in Bankruptcy.......................................40
12.5 Waiver.....................................................40
12.6 Assignment; Binding Effect.................................40
12.7 Independent Parties........................................41
12.8 Force Majeure..............................................41
12.9 Severability...............................................41
-viii-
{PAGE}
PAGE
12.10 Governing Law..............................................41
12.11 Entire Agreement; Modification.............................41
12.12. Counterparts...............................................42
Exhibit A SPECIFICATIONS...................................
Exhibit B SUITE............................................
Exhibit C PRESS RELEASES...................................
-ix-
{PAGE}
EXECUTION COPY
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
This Agreement (the "Agreement") is made effective as of the 29th day of
January, 2001 ("Effective Date"), by and between XOMA (US) LLC, a Delaware
limited liability company ("XOMA"), with offices at 2910 Seventh Street,
Berkeley, California 94710, USA, and Onyx Pharmaceuticals, Inc., a Delaware
corporation ("Onyx"), with offices at 3031 Research Drive, Richmond, California
94806, USA. XOMA and Onyx are sometimes referred to herein individually as a
"Party" and collectively as "Parties".
Recitals
WHEREAS, Onyx, a biotechnology company engaged in the discovery and
development of novel pharmaceuticals for cancer indications, has discovered and,
together with its collaboration partner, Pfizer Inc. ("Pfizer"), is developing a
novel replicating virus, ONYX-015 (also known as CI-1042 and further defined
below), as a biopharmaceutical product now in Phase III clinical trials.
Currently, ONYX-015 is manufactured at small scale by contract manufacturers;
WHEREAS, XOMA is a company that has developed substantial expertise in
process development, scale-up, and small- and large-scale manufacturing of its
own and its partners' biopharmaceutical products, and, in addition, has invested
in biopharmaceutical manufacturing facilities; and
WHEREAS, Onyx would like to engage XOMA to scale up and improve the process
for the manufacture of ONYX-015 and to manufacture and supply ONYX-015 in bulk
form for clinical trials and for the commercial launch of the ONYX-015 product,
and XOMA would like to provide such services to Onyx.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
promises and covenants set forth below, Onyx and XOMA mutually agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have the following
meanings:
1.1 "Acceptance Period" shall have the meaning given such term in Section
5.6(a).
1.2 "Affiliate" means any person or entity that, directly or indirectly,
through one or more intermediaries, Owns, is Owned by or is under
{PAGE}
common Ownership with, a Party, where "Own", "Owned" or "Ownership" refers to
(a) direct or indirect possession of at least fifty percent (50%) of the
outstanding voting securities of a corporation or a comparable ownership in any
other type of entity; or (b) the actual ability of an entity, person or group to
control and direct the management of the person or entity, whether by contract
or otherwise.
1.3 "Attainment of Commercial Scale" shall have the meaning given such term
in Section 4.2(b).
1.4 "Batch" means a specific quantity of Drug Substance that is intended to
have a uniform character and quality, within specified limits, and that is
produced according to a single manufacturing order during the same cycle of
manufacture.
1.5 "BLA" means a Biologics License Application filed with the FDA or other
equivalent application(s) for Regulatory Approval in a jurisdiction other than
the United States of America.
1.6 "cGMP" means the then current standards for manufacture of biologicals,
as set forth in the FD&C Act, and such standards of good manufacturing practice
as are required by the FDA or other Regulatory Authorities with jurisdiction
where ONYX-015 will be used in clinical trials or commercialized.
1.7 "Commercial Scale" means the [*]L nominal volume fermentation
bioreactor production scale for the ONYX-015 manufacturing process that will
result from scale-up work during the Development Phase, as it may be modified
pursuant to Section 4.2(c).
1.8 "Confidential Information" shall have the meaning given such term in
Section 10.1.
1.9 "Control", "Controls" and "Controlled" mean, with respect to a
particular item of information or Intellectual Property Right, that the
applicable Party owns or has a license to such item or right and has the ability
to grant to the other Party access to and a license or sublicense (as
applicable) under such item or rights as provided for herein without violating
the terms of any agreement or other arrangement with any Third Party.
1.10 "Delivery Date" shall have the meaning given such term in Section
5.3(a).
2.
{PAGE}
1.11 "Development Phase" shall have the meaning given such term in Section
2.2.
1.12 "Development Scale" means the [*]L, [*]L or comparable nominal volume
fermentation bioreactor production scales for the Drug Substance manufacturing
process transferred to XOMA and further developed under this Agreement.
1.13 "Drug Substance" means a formulation of purified bulk ONYX-015 that
has been manufactured and processed to the stage where it is suitable for
fill-and-finish procedures yielding the ONYX-015 product suitable for release
for use in clinical trials or commercial sales.
1.14 "Facility" shall have the meaning given such term in Section 3.1.
1.15 "FDA" means the United States Food and Drug Administration, or any
successor agency.
1.16 "FD&C Act" means the United States Food, Drug and Cosmetics Act and
applicable regulations and guidances promulgated thereunder, as amended from
time to time.
1.17 "Fully Burdened Staffing Costs" shall have the meaning given such term
in Section 6.4(a).
1.18 "IND" means an Investigational New Drug application as defined in the
FD&C Act and/or its equivalent in any country other than the United States of
America, the filing of which is necessary to commence clinical testing of
pharmaceutical products in humans.
1.19 "Intellectual Property Rights" means patents, copyrights, trademarks,
service marks, trade secrets, mask works, and applications for the foregoing, in
any country, supranational organization or territory of the world.
1.20 "Innovations" means inventions, discoveries, works of authorship,
trade secrets and other know-how or developments.
3.
{PAGE}
1.21 "Letter Agreement" shall have the meaning given such term in Section
2.1(a).
1.22 "Manufacturing Phase" shall have the meaning given such term in
Section 2.2.
1.23 "ONYX-015" means the formulation of the genetically engineered
adenovirus dl1520 described in US Patent Numbers 5,677,178 and 5,846,945,
selected by ONYX, that is currently in Phase III clinical trials.
1.24 "ONYX-015 Derivative" means ONYX-015 derivatized by engineering the
ONYX-015 genome to contain one or more additional transgenes that code for one
or more protein(s).
1.25 "Onyx Innovations" shall have the meaning given such term in Section
7.4(b).
1.26 "Onyx Partner" means any Third Party collaboration partner of Onyx
pursuant to a written agreement for the development and/or commercialization of
the ONYX-015 product, of which partner Onyx has given written notice to XOMA.
For clarity, Onyx's Third Party collaboration partner for such purposes as of
the Effective Date is Pfizer.
1.27 "Party" and "Parties" shall have the meanings given such terms,
respectively, in the first paragraph of this Agreement.
1.28 "Patents" means (i) United States issued patents, re-examinations,
reissues, renewals, extensions, patent term restorations, and foreign
counterparts of each of the foregoing; and (ii) pending applications for United
States patents and foreign counterparts thereof, whether issued or not.
1.29 "Project" shall have the meaning given such term in Section 2.1.
1.30 "Project Innovations" shall have the meaning given such term in
Section 7.4(d)(i).
1.31 "Project Team" shall have the meaning given such term in Section 2.3.
4.
{PAGE}
1.32 "Regulatory Approval" means all approvals, product and/or
establishment licenses, registrations or authorizations of all supranational,
national or local regulatory agencies and other governmental entities, necessary
329444
|
Citibank
As referenced in this Process Development and Manufacturing Agreement:
Citibank, N.A. – 30) days of receipt of the
invoice shall accrue interest at a rate equal to the lesser of prime rate as
posted by Citibank, N.A. , plus two percent (2%), or the highest interest rate
permitted under applicable law.
6.8 Records. XOMA will keep accurate books and
_____________
dt 638683
;
Genentech
As referenced in this Process Development and Manufacturing Agreement:
Genentech, Inc – other protein biopharmaceuticals for
disease targets that include immunological and inflammatory disorders,
infectious diseases and cancer. Late-stage programs include a collaboration with
Genentech, Inc . to develop the anti-CD11a antibody product for psoriasis (Phase
III) and kidney transplant rejection (Phase I/II), and an agreement with
_____________
Genentech, Inc – and other protein biopharmaceuticals for
disease targets that include immunological and inflammatory disorders,
infectious diseases and cancer. Late-stage programs include collaboration with
Genentech, Inc . to develop the anti-CD11a antibody product for psoriasis (Phase
III) and kidney transplant rejection (Phase I/II), and an agreement with
_____________
dt 686278
;
Onyx Pharma
As referenced in this Process Development and Manufacturing Agreement:
ONYX PHARMACEUTICALS, INC – Agreement has been omitted and
filed separately with the Securities and Exchange Commission.
PROCESS DEVELOPMENT AND MANUFACTURING AGREEMENT
between
XOMA (US) LLC
and
ONYX PHARMACEUTICALS, INC .
January 29, 2001
{PAGE}
TABLE OF CONTENTS
PAGE
1. Definitions.........................................................1
1.1 "Acceptance Period"........................................1
1.2 "Affiliate"................................................1
1.3 "
_____________
Onyx Pharmaceuticals, Inc – by and between XOMA (US) LLC, a Delaware
limited liability company ("XOMA"), with offices at 2910 Seventh Street,
Berkeley, California 94710, USA, and Onyx Pharmaceuticals, Inc ., a Delaware
corporation ("Onyx"), with offices at 3031 Research Drive, Richmond, California
94806, USA. XOMA and Onyx are sometimes referred to herein
_____________
Onyx Pharmaceuticals, Inc – Department Attention: Geoffrey E. Liebmann, Esq.
Fax No.: (510) 649-7571 Fax No.: (212) 269-5420
If to Onyx: With a copy to:
Onyx Pharmaceuticals, Inc . Cooley Godward LLP
3031 Research Drive Five Palo Alto Square
Richmond, CA 94806 3000 El Camino Real
Attention: CEO Palo Alto, CA
_____________
ONYX PHARMACEUTICALS, INC – Party hereto has caused this Agreement to be
signed and delivered by its duly authorized officer or representative as of the
Effective Date.
ONYX PHARMACEUTICALS, INC . XOMA (US) LLC
By: By:
-------------------------------- -----------------------------------
Name: Hollings C. Renton Name: Clarence L. Dellio
Title: Chief Executive Officer Title: Senior Vice President,
Operations
{
_____________
Onyx Pharmaceuticals, Inc – 3777
(310) 575-4848 www.lhai.com
{/TABLE}
ONYX AND XOMA ESTABLISH STRATEGIC PROCESS DEVELOPMENT AND MANUFACTURING
RELATIONSHIP
Berkeley, CA -- January 29, 2001 - Onyx Pharmaceuticals, Inc . (Nasdaq: ONXX) and
XOMA Ltd. (Nasdaq: XOMA) today announced that they have agreed to a strategic
process development and manufacturing relationship under
_____________
dt 611659
;
|
Pfizer
As referenced in this Process Development and Manufacturing Agreement:
Pfizer Inc – a biotechnology company engaged in the discovery and
development of novel pharmaceuticals for cancer indications, has discovered and,
together with its collaboration partner, Pfizer Inc . ("Pfizer"), is developing a
novel replicating virus, ONYX-015 (also known as CI-1042 and further defined
below), as a biopharmaceutical product
_____________
Pfizer Inc – s CI-1042 (also
known as ONYX-015), a therapeutic product to treat cancer. CI-1042, which is
being developed in collaboration with Pfizer Inc ., is currently in Phase III
testing for head and neck cancer.
The initial term of the agreement will be for five years,
_____________
Pfizer Inc – cell, is the most commonly altered gene in
human cancer. CI-1042 is being
C-4
{PAGE}
jointly developed by Onyx Pharmaceuticals and Pfizer Inc . under an agreement
signed in October 1999.
CI-1042, now in a Phase III clinical trial and various Phase I/II trials,
_____________
dt 611093
;
XOMA
As referenced in this Process Development and Manufacturing Agreement:
XOMA Ltd – com
{/TABLE}
ONYX AND XOMA ESTABLISH STRATEGIC PROCESS DEVELOPMENT AND MANUFACTURING
RELATIONSHIP
Berkeley, CA -- January 29, 2001 - Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) and
XOMA Ltd . (Nasdaq: XOMA) today announced that they have agreed to a strategic
process development and manufacturing relationship under which XOMA will
scale-up
_____________
dt 689530
;
More... |
Preview
Full Doc
| 2000 |
Manufacturing Agreement
Manufacturing Agreement (28K)
Doc #353026: Click preview link for longer preview.
MANUFACTURING AGREEMENT
This Manufacturing Agreement ("Agreement"), effective as of the 24th day
of June, 1997 (the "Effective Date"), is entered into by and between Argonaut
Technologies, Inc., a Delaware corporation having offices at 887 Industrial
Road, Suite G, San Carlos, California 94070, U.S.A. ("Argonaut"), and Merck &
Co, Inc., a New Jersey corporation having offices at One Merck Drive, Whitehouse
Station, New Jersey 08899 ("Merck").
BACKGROUND
A. Merck . . .
353026
|
Argonaut
As referenced in this Manufacturing Agreement:
Argonaut
Technologies, Inc – TEXT}
{PAGE} 1
EXHIBIT 10.25
MANUFACTURING AGREEMENT
This Manufacturing Agreement ("Agreement"), effective as of the 24th day
of June, 1997 (the "Effective Date"), is entered into by and between Argonaut
Technologies, Inc ., a Delaware corporation having offices at 887 Industrial
Road, Suite G, San Carlos, California 94070, U.S.A. ("Argonaut"), and Merck &
Co, Inc., a New Jersey corporation having offices
_____________
ARGONAUT TECHNOLOGIES, INC – abridgment of the powers of the arbitrators.
-8-
{PAGE} 9
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement
effective as of the Effective Date.
MERCK & CO., INC. ARGONAUT TECHNOLOGIES, INC .
By: /s/ THOMAS N. SALZMANN By: /s/ JAN HUGHES
-------------------------------- --------------------------------
Name: Thomas N. Salzmann Name: Jan Hughes
------------------------------ ------------------------------
(Typed or Printed) (Type or Printed)
Title: V.P. MRL Title: VP PRODUCT
_____________
Argonaut Technologies, Inc – per 6(d)
[*] Confidential Treatment Requested
{PAGE} 13
AMENDMENT
Effective June 15, 1998, the following products may be purchased under the
terms of the agreement dated June 24, 1997 between Argonaut Technologies, Inc .
and Merck & Co., Inc. This Amendment replaces the prior Exhibit A and Exhibit C.
EXHIBIT A & C
PRODUCT & NET PRICE LISTING
Instrumentation Products
- Quest(TM) 210 Manual Synthesizer (Part
_____________
ARGONAUT TECHNOLOGIES, INC – that reflect the terms of the Agreement for each part.
The parties have executed this Amendment by their duly authorized
representatives, effective as of the day and year written above.
ARGONAUT TECHNOLOGIES, INC . MERCK & CO., INC.
By: /s/ JAN HUGHES By:
------------------------------- -------------------------------
Jan Hughes Kevin Chapman
V.P. Product Development Director of Combinatorial Chemistry
[*] Confidential Treatment Requested
{/TEXT}
{/DOCUMENT}
_____________
dt 1330775
;
|
Merck
As referenced in this Manufacturing Agreement:
Merck &
Co – Date"), is entered into by and between Argonaut
Technologies, Inc., a Delaware corporation having offices at 887 Industrial
Road, Suite G, San Carlos, California 94070, U.S.A. ("Argonaut"), and Merck &
Co , Inc., a New Jersey corporation having offices at One Merck Drive, Whitehouse
Station, New Jersey 08899 ("Merck").
BACKGROUND
A. Merck desires to grant to Argonaut the right to manufacture,
_____________
MERCK & CO – and without any abridgment of the powers of the arbitrators.
-8-
{PAGE} 9
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement
effective as of the Effective Date.
MERCK & CO ., INC. ARGONAUT TECHNOLOGIES, INC.
By: /s/ THOMAS N. SALZMANN By: /s/ JAN HUGHES
-------------------------------- --------------------------------
Name: Thomas N. Salzmann Name: Jan Hughes
------------------------------ ------------------------------
(Typed or Printed) (Type or Printed)
Title: V.P.
_____________
Merck & Co – Treatment Requested
{PAGE} 13
AMENDMENT
Effective June 15, 1998, the following products may be purchased under the
terms of the agreement dated June 24, 1997 between Argonaut Technologies, Inc.
and Merck & Co ., Inc. This Amendment replaces the prior Exhibit A and Exhibit C.
EXHIBIT A & C
PRODUCT & NET PRICE LISTING
Instrumentation Products
- Quest(TM) 210 Manual Synthesizer (Part Number 900093) $[*]
Originally
_____________
MERCK & CO – terms of the Agreement for each part.
The parties have executed this Amendment by their duly authorized
representatives, effective as of the day and year written above.
ARGONAUT TECHNOLOGIES, INC. MERCK & CO ., INC.
By: /s/ JAN HUGHES By:
------------------------------- -------------------------------
Jan Hughes Kevin Chapman
V.P. Product Development Director of Combinatorial Chemistry
[*] Confidential Treatment Requested
{/TEXT}
{/DOCUMENT}
_____________
dt 736868
|
Preview
Full Doc
| 2001 |
Manufacturing Agreement
Manufacturing Agreement (47K)
Doc #991634: Click preview link for longer preview.
<DESCRIPTION>MANUFACTURING AGREEMENT
<TEXT>
MANUFACTURING AGREEMENT
This Manufacturing Agreement ("AGREEMENT") is made and entered into as
of December 29, 2000 (the "EFFECTIVE Date") by and between, Telenetics
Corporation (the "BUYER"), a California corporation, having its place of
business at 25111 Arctic Ocean, Lake Forest, CA 92630, and Comtel Electronics,
Inc. ("SELLER"), a Delaware corporation and a division of Comtel Holdings, Inc.,
having its place of . . .
991634
|
Motorola
As referenced in this Manufacturing Agreement:
Motorola, Inc – to "Buyer" and "Seller"
shall include their respective Affiliates (as that term is defined in SECTION
11.2 herein).
1. PREAMBLE.
---------
WHEREAS, the Buyer has entered into an agreement with Motorola, Inc .
known as the Manufacturing License and Distribution Agreement (the "MOTOROLA
AGREEMENT") to produce certain transmission products and desires to outsource
certain aspects of the manufacturing, assembly and testing (the "
_____________
dt 1716944
| |
Preview
Full Doc
| 2006 |
Commercial Manufacturing Agreement
Commercial Manufacturing Agreement (61K)
Doc #1027058: Click preview link for longer preview.
COMMERCIAL MANUFACTURING AGREEMENT
This Commercial Manufacturing Agreement (�Agreement�) is made this 30th day of December, 2005, by and between Cardinal Health PTS, LLC, having a place of business at 14 Schoolhouse Road, Somerset, NJ 08873 (�Cardinal Health�) and CollaGenex Pharmaceuticals, Inc. (�Client�), having its principal place of business at 41 University Drive, Suite 200, Newtown, PA 18940.
WHEREAS, Cardinal Health provides contract pharmaceutical development, manufacturing, packaging, analytical, and sales and marketing services to the . . .
1027058
|
Cardinal Health
As referenced in this Commercial Manufacturing Agreement:
Cardinal Health, Inc – to:
To Cardinal Health:
Cardinal Health PTS, LLC
14 Schoolhouse Road
Somerset, NJ 08873
Attn: Vice President, Business Development, Solid Oral Pharmaceuticals
Facsimile: (732) 537-6493
With a copy to:
Cardinal Health, Inc .
7000 Cardinal Place
Dublin, Ohio 43017
Attn: Associate General Counsel,
Pharmaceutical Technologies and Services
Facsimile: (614) 757-5051
ARTICLE 18
MISCELLANEOUS
18.1 Entire Agreement; Amendments. This Agreement is
_____________
dt 1419884
;
|
CollaGenex
As referenced in this Commercial Manufacturing Agreement:
CollaGenex Pharmaceuticals, Inc – is made this 30th day of December, 2005, by and between Cardinal Health PTS, LLC, having a place of business at 14 Schoolhouse Road, Somerset, NJ 08873 (Cardinal Health) and CollaGenex Pharmaceuticals, Inc . (Client), having its principal place of business at 41 University Drive, Suite 200, Newtown, PA 18940.
WHEREAS, Cardinal Health provides contract pharmaceutical development, manufacturing, packaging, analytical, and sales and
_____________
CollaGenex Pharmaceuticals, Inc – or delivered by a reliable overnight delivery service, to the address for such party below or such other address as a party may designate from time to time:
To Client:
CollaGenex Pharmaceuticals, Inc .
41 University Drive, Suite 200
Newtown, PA 18940
Attn:
With a copy to:
To Cardinal Health:
Cardinal Health PTS, LLC
14 Schoolhouse Road
Somerset, NJ 08873
Attn: Vice President,
_____________
COLLAGENEX PHARMACEUTICALS INC – the public disclosure.
IN WITNESS WHEREOF, the parties have caused their duly authorized representative to execute this Agreement effective as of the date first written above.
CARDINAL HEALTH PTS, LLC
COLLAGENEX PHARMACEUTICALS INC .
By:
/s/ David Wood
By:
/s/ Colin Stewart
Name:
David Wood
Name:
Colin Stewart
Its:
VP/GM Controlled Release
Its:
President and CEO
2-21-06
3-1-06
_____________
dt 1396067
|
Preview
Full Doc
| 2004 |
Manufacturing Agreement
Manufacturing Agreement (121K)
Doc #1246546: Click preview link for longer preview.
portions are marked by a series of asterisks.
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this "AGREEMENT") is made and entered into on
December 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each . . .
1246546
|
Abbott Labs
As referenced in this Manufacturing Agreement:
Abbott Laboratories, – 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each are
sometimes referred to hereinafter
_____________
Abbott Laboratories
– by either Party will be faxed as quickly as
possible and in no event later than five (5) Business Days after receipt by
the recipient to the other Party to:
Abbott Laboratories
1401 Sheridan Road
D-44K, Bldg. RI
North Chicago, Illinois 60064-6255
Attention: Quality Assurance Department
Facsimile Number: (847) 937-4261
and
Prestige Brands International, Inc.
26811 South Bay
_____________
Abbott Laboratories
– 948-8551
with copies to:
Hunton & Williams
951 East Byrd Street
Richmond, Virginia 23219
Attn: T. Justin Moore, III, Esq.
Facsimile Number: (804) 788-8218
If to Seller, to:
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General
Counsel
Facsimile Number: (847) 938-6277
with copies to:
_____________
ABBOTT LABORATORIES
– lt;Page>
IN WITNESS WHEREOF, the Parties have affixed hereunto their authorized
signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
<Page>
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
<Table>
<
_____________
Abbott Laboratories
– signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
<Page>
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
<Table>
<Caption>
LIST NUMBER DESCRIPTION
<S> <C>
02541-04-
_____________
dt 1809574
;
| |
Preview
Full Doc
| 2005 |
Manufacturing Agreement
Manufacturing Agreement (101K)
Doc #1258100: Click preview link for longer preview.
MANUFACTURING AGREEMENT
between
ABBOTT GMBH & CO. KG
and
RELIANT PHARMACEUTICALS, LLC
Dated as of December 3, 2003
1
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this �Agreement�) is made and entered into as of December 3, 2003, by and between Reliant Pharmaceuticals, LLC, a Delaware limited liability company (�Buyer�), and Abbott GmbH & Co. KG (�Seller�). Buyer and Seller are sometimes referred to hereinafter individually, as a �Party� and collectively as the �Parties.�
W I . . .
1258100
|
Abbott Labs
As referenced in this Manufacturing Agreement:
Abbott Laboratories, – Buyer and Seller are sometimes referred to hereinafter individually, as a ?Party? and collectively as the ?Parties.?
W I T N E S S E T H:
WHEREAS, Buyer and Abbott Laboratories, an Illinois corporation (?Parent?), have entered into an Asset Purchase Agreement of even date herewith (the ?Asset Purchase Agreement?); and
WHEREAS, in connection with the transactions contemplated by the
_____________
Abbott Laboratories – Product Complaints?) received by either Party will be promptly faxed and in no event later than five (5) Business Days after receipt by the recipient to the other Party to:
Abbott Laboratories
1401 Sheridan Road
D-44K, Bldg. R1
North Chicago, IL 60064-6255
Attention: Quality Assurance Department
Fax: 847-937-4261
and
Reliant Pharmaceuticals, LLC
110 Allen Road
Liberty Corner,
_____________
Abbott Laboratories
– 5800
Chicago, IL 60606
Attn: Michael A. Pucker
Facsimile: (312) 993-9767
26
If to Seller, to:
Abbott GmbH & Co. KG
Postfach 21085
D-67008 Ludwigshafen
Attn: General Manager
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General Counsel
Facsimile Number: (847) 938-6277
Abbott Laboratories
Dept.
_____________
Abbott Laboratories
– General Manager
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General Counsel
Facsimile Number: (847) 938-6277
Abbott Laboratories
Dept. 50C, Bldg. J23
200 Abbott Park Road
Abbott Park, Illinois 60064-6162
Attn: Manager, Contract Manufacturing
Facsimile Number: (847) 938-9319
provided, however, that if either Party shall
_____________
Abbott Laboratories, – IN WITNESS WHEREOF, the Parties have affixed hereunto their authorized signature as follows:
RELIANT PHARMACEUTICALS, LLC
ABBOTT GMBH & CO. KG
By:
By:
Name:
Name:
Title:
Title:
By:
Name:
Title:
Abbott Laboratories, an Illinois corporation and the parent of Seller, hereby (i) guarantees payment and performance of all of Seller?s and its Affiliates obligations under this Agreement, and (ii) agrees
_____________
dt 1809575
;
| |
Preview
Full Doc
| 2005 |
Manufacturing Agreement
Manufacturing Agreement (94K)
Doc #1258197: Click preview link for longer preview.
MANUFACTURING AGREEMENT
between
ABBOTT GMBH & CO. KG
and
RELIANT PHARMACEUTICALS, LLC
Dated as of December 3, 2003
1
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this �Agreement�) is made and entered into as of December 3, 2003, by and between Reliant Pharmaceuticals, LLC, a Delaware limited liability company (�Buyer�), and Abbott GmbH & Co. KG (�Seller�). Buyer and Seller are sometimes referred to hereinafter individually, as a �Party� and collectively as the �Parties.�
W I . . .
1258197
|
Abbott Labs
As referenced in this Manufacturing Agreement:
Abbott Laboratories, – Buyer and Seller are sometimes referred to hereinafter individually, as a ?Party? and collectively as the ?Parties.?
W I T N E S S E T H:
WHEREAS, Buyer and Abbott Laboratories, an Illinois corporation (?Parent?), have entered into an Asset Purchase Agreement of even date herewith (the ?Asset Purchase Agreement?); and
WHEREAS, in connection with the transactions contemplated by the
_____________
Abbott Laboratories – Product Complaints?) received by either Party will be promptly faxed and in no event later than five (5) Business Days after receipt by the recipient to the other Party to:
Abbott Laboratories
1401 Sheridan Road
D-44K, Bldg. R1
North Chicago, IL 60064-6255
Attention: Quality Assurance Department
Fax: 847-937-4261
and
Reliant Pharmaceuticals, LLC
110 Allen Road
Liberty Corner,
_____________
Abbott Laboratories
– 5800
Chicago, IL 60606
Attn: Michael A. Pucker
Facsimile: (312) 993-9767
26
If to Seller, to:
Abbott GmbH & Co. KG
Postfach 21085
D-67008 Ludwigshafen
Attn: General Manager
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General Counsel
Facsimile Number: (847) 938-6277
Abbott Laboratories
Dept.
_____________
Abbott Laboratories
– General Manager
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General Counsel
Facsimile Number: (847) 938-6277
Abbott Laboratories
Dept. 50C, Bldg. J23
200 Abbott Park Road
Abbott Park, Illinois 60064-6162
Attn: Manager, Contract Manufacturing
Facsimile Number: (847) 938-9319
provided, however, that if either Party shall
_____________
Abbott Laboratories, – IN WITNESS WHEREOF, the Parties have affixed hereunto their authorized signature as follows:
RELIANT PHARMACEUTICALS, LLC
ABBOTT GMBH & CO. KG
By:
By:
Name:
Name:
Title:
Title:
By:
Name:
Title:
Abbott Laboratories, an Illinois corporation and the parent of Seller, hereby (i) guarantees payment and performance of all of Seller?s and its Affiliates obligations under this Agreement, and (ii) agrees
_____________
dt 1809576
;
| |
Preview
Full Doc
| 2004 |
Manufacturing Agreement
Manufacturing Agreement (121K)
Doc #1258630: Click preview link for longer preview.
portions are marked by a series of asterisks.
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this "AGREEMENT") is made and entered into on
December 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each . . .
1258630
|
Abbott Labs
As referenced in this Manufacturing Agreement:
Abbott Laboratories, – 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each are
sometimes referred to hereinafter
_____________
Abbott Laboratories
– by either Party will be faxed as quickly as
possible and in no event later than five (5) Business Days after receipt by
the recipient to the other Party to:
Abbott Laboratories
1401 Sheridan Road
D-44K, Bldg. RI
North Chicago, Illinois 60064-6255
Attention: Quality Assurance Department
Facsimile Number: (847) 937-4261
and
Prestige Brands International, Inc.
26811 South Bay
_____________
Abbott Laboratories
– 948-8551
with copies to:
Hunton & Williams
951 East Byrd Street
Richmond, Virginia 23219
Attn: T. Justin Moore, III, Esq.
Facsimile Number: (804) 788-8218
If to Seller, to:
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General
Counsel
Facsimile Number: (847) 938-6277
with copies to:
_____________
ABBOTT LABORATORIES
– lt;Page>
IN WITNESS WHEREOF, the Parties have affixed hereunto their authorized
signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
<Page>
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
<Table>
<
_____________
Abbott Laboratories
– signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
<Page>
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
<Table>
<Caption>
LIST NUMBER DESCRIPTION
<S> <C>
02541-04-
_____________
dt 1809577
;
| |
Preview
Full Doc
| 2000 |
Manufacturing Agreement
Manufacturing Agreement (59K)
Doc #1577162: Click preview link for longer preview.
CONFIDENTIAL PORTION HAS BEEN SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
MANUFACTURING AGREEMENT
This Manufacturing Agreement (hereinafter the "Agreement"),
made and effective as of the 15th day of May, 1994, by and between Merck & Co.,
Inc., a corporation incorporated under the laws of the State of New Jersey,
U.S.A., having its office at One Merck Drive, Whitehouse Station, New Jersey
08889, U.S.A. (hereinafter referred to as "MERCK") and Koffolk, Ltd. and Philipp
Brothers Chemicals, Inc., companies organized . . .
1577162
|
Merck
As referenced in this Manufacturing Agreement:
Merck & Co – SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
MANUFACTURING AGREEMENT
This Manufacturing Agreement (hereinafter the "Agreement"),
made and effective as of the 15th day of May, 1994, by and between Merck & Co .,
Inc., a corporation incorporated under the laws of the State of New Jersey,
U.S.A., having its office at One Merck Drive, Whitehouse Station, New Jersey
08889, U.
_____________
Merck & Co – maintain
general/comprehensive liability including products liability insurance
in an amount not less than one million dollars per occurrence and five
million dollars in the aggregate. Such policy shall name Merck & Co .,
Inc. as an "Additional Insured". KOFFOLK shall provide Certificates of
Insurance evidencing said insurance, which will be placed with insurers
acceptable to MERCK, and KOFFOLK shall provide written notice
_____________
Merck & Co – Philipp Brothers Chemicals, Inc.
One Parker Plaza
Fort Lee, New Jersey 07024 U.S.A.
Telephone: (201) 944-6020
Panafax: (201) 944-5937
Attention: Jack C. Bendheim
If to MERCK:
Merck & Co ., Inc.
One Merck Drive
Whitehouse Station, New Jersey 08889 U.S.A.
Telephone: (908) 423-3068
Panafax: (908) 735-1106
Attention: Vice President, Business Affairs, Merck Manufacturing
Division
IN
_____________
MERCK & CO – Division
IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed in duplicate by their representatives duly authorized
as of the day and year first above written.
MERCK & CO .
By: /s/
---
Title: V.P.
KOFFOLK, LTD.
By: /s/
---
Title: G.M.
PHILIPP BROTHERS CHEMICALS, INC.
By: /s/ Jack C. Bendheim
--------------------
Title: President
15
Schedule A
Specifications
--------------
CONFIDENTIAL
_____________
dt 1681225
;
| |
Preview
Full Doc
| 2004 |
Manufacturing Agreement
Manufacturing Agreement (121K)
Doc #2157928: Click preview link for longer preview.
portions are marked by a series of asterisks.
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this "AGREEMENT") is made and entered into on
December 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each . . .
2157928
|
Abbott Labs
As referenced in this Manufacturing Agreement:
Abbott Laboratories, – 30, 2002, by and between Prestige Brands International, Inc., a
Virginia corporation having a place of business at 26811 South Bay Drive, Suite
300, Bonita Springs, Florida 34134 ("BUYER"), and Abbott Laboratories, an
Illinois corporation having a place of business at One Hundred Abbott Park Road,
Abbott Park, Illinois, 60064-3500 ("SELLER"). Buyer and Seller each are
sometimes referred to hereinafter
_____________
Abbott Laboratories
– by either Party will be faxed as quickly as
possible and in no event later than five (5) Business Days after receipt by
the recipient to the other Party to:
Abbott Laboratories
1401 Sheridan Road
D-44K, Bldg. RI
North Chicago, Illinois 60064-6255
Attention: Quality Assurance Department
Facsimile Number: (847) 937-4261
and
Prestige Brands International, Inc.
26811 South Bay
_____________
Abbott Laboratories
– 941) 948-8551
with copies to:
Hunton & Williams
951 East Byrd Street
Richmond, Virginia 23219
Attn: T. Justin Moore, III, Esq.
Facsimile Number: (804) 788-8218
If to Seller, to:
Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General
Counsel
Facsimile Number: (847) 938-6277
with copies to:
_____________
ABBOTT LABORATORIES
– Party.
* * * * * * * *
20
{Page}
IN WITNESS WHEREOF, the Parties have affixed hereunto their authorized
signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
{Page}
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
{Table}
{Caption}
LIST NUMBER DESCRIPTION
{S} {
_____________
Abbott Laboratories
– signature as follows:
PRESTIGE BRANDS INTERNATIONAL,
INC.
By: /s/ THEODORE HOST
-------------------------------------
Theodore J. Host
Chief Executive Officer
ABBOTT LABORATORIES
By: /s/ GARY FLYNN
-------------------------------------
Gary L. Flynn
President, Ross Products Division,
Abbott Laboratories
{Page}
EXHIBIT 1.1 - PRODUCTS
Clear eyes(R)
UNITED STATES
{Table}
{Caption}
LIST NUMBER DESCRIPTION
{S} {C}
02541-04-05 Clear Eyes Lubricant
02541-04-09 Clear Eyes Lubricant
_____________
dt 1563508
;
|
 Jones Day
As referenced in this Manufacturing Agreement:
Jones, Day, Reavis & Pogue – Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Park, Illinois 60064-6020
Attn: Senior Vice President, Secretary and General
Counsel
Facsimile Number: (847) 938-6277
with copies to:
Jones, Day, Reavis & Pogue
1900 Huntington Center
Columbus, Ohio 43215
Attn: Randall M. Walters
Facsimile Number: (614) 461-4198
19
{Page}
provided, however, that if any Party shall have designated a different address
_____________
dt 1578121
|
Preview
Full Doc
| 2007 |
Manufacturing Agreement
Manufacturing Agreement (84K)
Doc #2881675: Click preview link for longer preview.
GFA Brands, Inc. and Ventura Foods, LLC
Page 1 of 47
March 2, 2007
Certain portions hereof denoted with ?[***]? have been omitted pursuant to a request for confidential treatment. An unredacted copy hereof has been filed separately with the United States Securities and Exchange Commission pursuant to a request for confidential treatment.
MANUFACTURING AGREEMENT
FOR
MARGARINE AND SPREADS
Effective Date: March 2, 2007
This Manufacturing Agreement (the ?Agreement?) is made and entered into as of the Effective Date shown above by and . . .
2881675
| | |