Tennessee | 2834 | 62-1765329 | ||
(State or other jurisdiction
of
incorporation or organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer
Identification No.) |
Martin S. Brown, Esq.
Virginia Boulet, Esq. Adams and Reese LLP 424 Church Street, Suite 2800 Nashville, Tennessee 37219 (615) 259-1450 |
Donald J. Murray, Esq.
Dewey & LeBoeuf LLP 1301 Avenue of the Americas New York, New York 10019-6092 (212) 259-8000 |
ITEM 13.
OTHER EXPENSES OF
ISSUANCE AND DISTRIBUTION.
Item
Amount
$
4,000
$
12,000
$
100,000
$
271,000
$
875,000
$
1,200,000
$
20,000
$
15,000
$
803,000
$
3,300,000
ITEM 14.
INDEMNIFICATION
OF DIRECTORS AND OFFICERS.
ITEM 15.
RECENT SALES OF
UNREGISTERED SECURITIES.
ITEM 16.
EXHIBITS AND
FINANCIAL STATEMENT SCHEDULES.
No.
Description
First Amendment to Manufacturing and Supply Agreement for
N-Acetylcysteine, dated November 16, 2006, by and between
Bioniche Teoranta and Cumberland Pharmaceuticals Inc.
Second Amendment to Manufacturing and Supply Agreement for
N-Acetylcysteine, dated March 25, 2008, by and between
Bioniche Teoranta and Cumberland Pharmaceuticals Inc.
Cardinal Health Contract Sales and Services for Cumberland
Pharmaceuticals Inc. Dedicated Sales Force Agreement, dated
May 16, 2006, by and between Cardinal Health PTS, LLC and
Cumberland Pharmaceuticals Inc.
First Amendment to Contract Sales and Service Agreement, dated
July 19, 2006, by and between Cardinal Health PTS, LLC and
Cumberland Pharmaceuticals Inc.
Second Amendment to Contract Sales and Service Agreement, dated
June 1, 2007, by and between Cumberland Pharmaceuticals
Inc. and Inventiv Commercial Services, LLC, as successor in
interest to Cardinal Health PTS, LLC.
Third Amendment to Contract Sales and Service Agreement, dated
March 26, 2008, by and between Cumberland Pharmaceuticals
Inc. and Ventiv Commercial Services, LLC.
Distribution Services Agreement, dated August 3, 2000, by
and between CORD Logistics, Inc. and Cumberland Pharmaceuticals
Inc.
Strategic Alliance Agreement, dated July 21, 2000, by and
between F.H. Faulding & Co. Limited and Cumberland
Pharmaceuticals Inc., including notification of assignment from
F.H. Faulding & Co. Limited to Mayne Pharma Pty Ltd., dated
April 16, 2002
Kristalose Agreement, dated April 7, 2006, by and among
Inalco Biochemicals, Inc., Inalco S.p.A., and Cumberland
Pharmaceuticals Inc.
Amendment to Kristalose Agreement, dated April 3, 2008, by
and between Inalco S.p.A., Inalco Biochemicals, Inc., and
Cumberland Pharmaceuticals Inc.
License Agreement, dated May 28, 1999, by and between
Vanderbilt University and Cumberland Pharmaceuticals Inc.
Employment Agreement effective as of January 1, 2008 by and
between A.J. Kazimi and Cumberland Pharmaceuticals Inc.
Employment Agreement effective as of January 1, 2008 by and
between Jean W. Marstiller and Cumberland Pharmaceuticals Inc.
Employment Agreement effective as of January 1, 2008 by and
between Leo Pavliv and Cumberland Pharmaceuticals Inc.
Employment Agreement effective as of January 1, 2008 by and
between J. William Hix and Cumberland Pharmaceuticals Inc.
Employment Agreement effective as of January 1, 2008 by and
between David L. Lowrance and Cumberland Pharmaceuticals Inc.
Second Amended and Restated Loan Agreement by and between
Cumberland Pharmaceuticals Inc. and Bank of America, N.A., dated
April 6, 2006.
First Amendment to Second Amended and Restated Loan Agreement by
and between Cumberland Pharmaceuticals Inc. and Bank of America,
N.A., dated December 31, 2006.
Second Amendment to Second Amended and Restated Loan Agreement
by and between Cumberland Pharmaceuticals Inc. and Bank of
America, N.A., dated July 18,
2007.
No.
Description
Third Amendment to Second Amended and Restated Loan Agreement,
by and between Cumberland Pharmaceuticals Inc. and Bank of
America, N.A., dated April 6, 2008.
1999 Stock Option Plan of Cumberland Pharmaceuticals Inc.
2007 Long-Term Incentive Compensation Plan of Cumberland
Pharmaceuticals Inc.
2007 Directors Compensation Plan of Cumberland
Pharmaceuticals Inc.
Form of Indemnification Agreement between Cumberland
Pharmaceuticals Inc. and all members of its Board of Directors.
Lease Agreement, dated September 10, 2005, by and between
Nashville Hines Development, LLC and Cumberland Pharmaceuticals
Inc.
First Amendment to Office Lease Agreement, dated April 25,
2008, by and between 2525 West End, LLC (successor in interest
to Nashville Hines Development LLC) and Cumberland
Pharmaceuticals Inc.
Sublease Agreement, dated December 14, 2006, by and between
Robert W. Baird & Co. Incorporated and Cumberland
Pharmaceuticals Inc.
Addendum to Sublease Agreement, dated May 5, 2007, by and
between Robert W. Baird & Co. Incorporated and
Cumberland Pharmaceuticals Inc. and consented to by Nashville
Hines Development, LLC.
Amended and Restated Lease Agreement, dated November 11,
2004, by and between The Gateway to Nashville LLC and Cumberland
Emerging Technologies, Inc.
First Amendment to Amended and Restated Lease Agreement, dated
August 23, 2005, by and between The Gateway to Nashville
LLC and Cumberland Emerging Technologies, Inc.
Second Agreement to Amended and Restated Lease Agreement, dated
January 9, 2006, by and between The Gateway to Nashville LLC and
Cumberland Emerging Technologies, Inc.
Manufacturing Agreement, dated February 6, 2008, by and between
Bayer HealthCare, LLC, and Cumberland Pharmaceuticals Inc.
Subsidiaries of Cumberland Pharmaceuticals Inc.
Consent of KPMG LLP.
Consent of Adams and Reese, LLP (contained in Exhibit 5).
Consent of Morgan Joseph & Co. Inc.
Powers of Attorney (contained on the signature page of
Registration Statement on Form S-1 filed on May 1,
2007).
**
Previously filed.
#
Indicates a management contract or compensatory plan.
Confidential treatment has been granted for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
(b)
See Schedule IIValuation and qualifying accounts
included in our audited financial statements included elsewhere
in this registration statement.
ITEM 17.
UNDERTAKINGS.
By:
Chairman and CEO
(Principal Executive Officer)
Signature
Title
Date
Chairman and CEO (Principal Executive Officer)
May 21, 2008
Vice President and CFO (Principal Financial and Accounting
Officer)
May 21, 2008
Director
May 21, 2008
Director
May 21, 2008
Director
May 21, 2008
Director
May 21, 2008
*By:
Attorney-in-Fact
** Previously filed.
#
Indicates a management contract or compensatory plan.
Confidential treatment has been granted for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
Confidential treatment has been requested for portions of this
exhibit. These portions have been omitted from the Registration
Statement and submitted separately to the Securities and
Exchange Commission.
1. | Paragraph 1.18 defines TERRITORY as having the meaning set forth in Schedule III. Schedule III of the Agreement, and therefore the TERRITORY, is hereby amended and restated as follows: | ||
The United States of America, Australia, New Zealand, Singapore, Malaysia, Hong Kong, China, Vietnam, Thailand, Taiwan, Korea, the Philippines and each of their territories and possessions on the Effective Date of this Second Amendment. | |||
2. | Paragraph 5.6 is hereby amended by adding clause (d) as follows: |
3. | The following is hereby added to the end of Paragraph 2.7 of the existing Agreement: | ||
In the event that CUMBERLAND arranges to sell Drug Product or have Drug Product sold in a region or market whose regulatory authority requires a unique label; or if CUMBERLAND contracts a third party to sell Drug Product, and this third party requires a unique label, then BIONICHE shall divide the Labeling of Drug Product in the applicable Purchase Order between the unique label and the usual and customary CUMBERLAND label in accordance with CUMBERLANDs request. In such an event, CUMBERLAND will provide such unique label to BIONICHE and clearly identify the division of Drug Product between the two labels on any applicable Purchase Order. | |||
Upon request by CUMBERLAND, BIONICHE will ship a whole or partial Order of the Drug Product to fulfill the commitments in a given region or market directly to a secondary distributor or to a third party or its identified distributor. In such an event, CUMBERLAND will identify on the applicable Purchase Order the requested shipment destination and any shipping instructions. |
4. | In the section entitled Pricing in SCHEDULE I, the first paragraph is hereby amended and restated as follows: | ||
Pursuant to Paragraph 2.10(a) of the Original Agreement, the price to be paid by CUMBERLAND to BIONICHE in the year 2008 for the Drug Products ordered from BIONICHE is as follows: |
5. | In the section entitled Pricing in SCHEDULE I, the first sentence of the fourth paragraph is hereby amended and restated as follows: | ||
In addition, CUMBERLAND shall pay to BIONICHE a royalty equal to [***] percent ([***]%) of Net Sales (as defined herein) during each calendar year through December 31, 2010, and during the period thereafter ending January 23, 2011 on product manufactured by BIONICHE or by a 3 rd party contractor for CUMBERLAND provided that CUMBERLAND shall pay BIONICHE such royalty on a quarterly basis within [***] days after the last day of the applicable calendar quarter. |
2
6. | Miscellaneous. |
3
CUMBERLAND:
CUMBERLAND PHARMACEUTICALS INC. |
||||
By: | /s/ A.J. Kazimi | |||
Name: | A. J. Kazimi | |||
Title: | Chief Executive Officer | |||
BIONICHE:
BIONICHE TEORANTA |
||||
By: | /s/ George Zorich | |||
Name: | George S Zorich | |||
Title: | President, North American Operations | |||
4
2
VENTIV COMMERCIAL SERVICES, LLC
|
||||
By: | /s/ Terrell G. Herring | |||
Name: | Terrell G. Herring | |||
Title: | President and CEO | |||
CUMBERLAND PHARMACEUTICALS, INC.
|
||||
By: | /s/ A.J. Kazimi | |||
Name: | A.J. Kazimi | |||
Title: | CEO |
3
Monthly Fee Commencing
on the Effective Date and Continuing Until the Hire Date |
Monthly Fee
Commencing on the Hire Date and Continuing Until the First Anniversary of the Hire Date |
Monthly Fee
Commencing on the First Anniversary of the Hire Date and Continuing Until the Second Anniversary of the Hire Date |
||
$258,482 | $442,484 | $453,615 |
4
5
1
INALCO S.P.A
|
||||
By: | /s/ Giovanni Cipolletti | |||
Name: | Giovanni Cipolletti | |||
Its: President | ||||
INALCO BIONCHEMICALS, INC.
|
||||
By: | /s/ Eric Lowe | |||
Name: | Eric Lowe | |||
Its: President | ||||
CUMBERLAND PHARMACEUTICALS INC.
|
||||
By: | /s/ A.J. Kazimi | |||
Name: | A.J. Kazimi | |||
Its: Chief Executive Officer | ||||
2
-2-
-3-
BORROWER:
CUMBERLAND PHARMACEUTICALS, INC. |
||||
By: | /s/ A.J. Kazimi | |||
Name: | A.J. Kazimi | |||
Title: | Chief Executive Officer | |||
By: | /s/ A.J. Kazimi | |||
Name: | A.J. Kazimi | |||
Title: | Chief Executive Officer |
-4-
BANK:
BANK OF AMERICA, N.A. |
||||
By: | /s/ Suzanne B. Smith | |||
Name: | Suzanne B. Smith | |||
Title: | Senior Vice President | |||
-5-
-2-
-3-
LANDLORD:
|
2525 WEST END, LLC , a Delaware limited liability company |
|
By: | Cash Flow Asset Management, L.P., | ||
|
a Texas limited partnership, its sole manager |
|
By: | CFAM GP, L.L.C., | ||
|
a Texas limited liability company, its sole general partner |
By: | /s/ John W. Emerson | |||
Name: | John W. Emerson | |||
Title: |
Vice President
Effective Date: April 25 , 2008 |
|||
TENANT:
|
CUMBERLAND PHARMACEUTICALS INC., a Tennessee corporation |
By: | /s/ A.J. Kazimi | |||
Name: | A.J. Kazimi | |||
Title: | CEO |
Ex. A-i
Ex. B-i
FIRST
ORIGINAL
EXPANSION
PREMISES
SPACE
FIRST
ORIGINAL
EXPANSION
ANNUAL
ANNUAL
PREMISES
SPACE
BASE
BASE
RENTAL
RENTAL
MONTHLY
BASE
PERIOD
RATE
RATE
RSF
RSF
RENTAL
5/30/2008
$
[***]
6,341
$
[***]
7/31/2008
$
[***]
$
[***]
6,341
2,950
$
[***]
12/31/2008
$
[***]
$
[***]
6,341
2,950
$
[***]
5/30/2009
$
[***]
$
[***]
6,341
2,950
$
[***]
12/31/2009
$
[***]
$
[***]
6,341
2,950
$
[***]
5/31/2010
$
[***]
$
[***]
6,341
2,950
$
[***]
12/31/2010
$
[***]
$
[***]
6,341
2,950
$
[***]
5/31/2011
$
[***]
2,950
$
[***]
5/31/2012
$
[***]
2,950
$
[***]
5/31/2013
$
[***]
2,950
$
[***]
5/31/2014
$
[***]
2,950
$
[***]
5/31/2015
$
[***]
2,950
$
[***]
12/31/2015
$
[***]
2,950
$
[***]
LANDLORD:
THE GATEWAY TO NASHVILLE, L.L.C. |
||||
By: | /s/ Zachary B. Liff | |||
Its: Chief Manager | ||||
TENANT:
CUMBERLAND EMERGING TECHNOLOGIES, INC. |
||||
By: | /s/ A.J. Kazimi | |||
Its: C.E.O. | ||||
1. | DEFINITIONS | |
For the purposes of this Agreement, the following terms shall have the meanings set forth below: | ||
1.1 | Active Pharmaceutical Ingredient shall mean the pharmacologically active agent for the manufacture of a Product. | |
1.2 | Affiliate Any person or business entity which directly or indirectly controls, is controlled by, or is under common control with a party to this Agreement. In this Agreement, an Affiliate of Cumberland will include the distributor of Products. A business entity shall be deemed to control another business entity, if it owns directly or indirectly, fifty percent (50%) or more of the outstanding voting securities, capital stock, or other comparable equity or ownership interest of such business entity, or exercises equivalent influence over such entity. If the laws of the jurisdiction in which such entity operates prohibit ownership by a party of fifty percent (50%) or more, control shall be deemed to exist at the maximum level of ownership allowed by such jurisdiction. | |
1.3 | Components All materials (including, Active Pharmaceutical Ingredient, packaging and shipping materials), whether produced by Bayer or procured from Cumberland or a third party vendor, which are incorporated into the Product by Bayer in the performance of its Manufacturing Services. | |
1.4 | Cumberland Components means those Components which are furnished by Cumberland or by a third party vendor on behalf of Cumberland. | |
1.5 | Drug Master File shall mean the Drug Master File for manufacturing an Active Latent Pharmaceutical Ingredient filed with the United States Food & Drug Administration, and the equivalent filing with the governing health authority of any other country. | |
1.6 | Latent Defect Any instance where all or portion of batch of a Product fails to conform to the |
1.7 | Legal Requirements Any present and future national, state, or local law (whether under statute, rule, regulation, or otherwise), including, without limitation, US Federal Food, Drug and Cosmetic Act of 1934, and the regulations promulgated there under, as the same may be amended from time to time (the Act); requirements under permits, orders, decrees, judgments, or directives; and requirements of a Regulatory Agency and any other applicable government authorities, including without limitation Good Manufacturing Practices as promulgated by the United States Food and Drug Administration and specified in the U.S. Code of Federal Regulations Parts 210 and 211, as amended from time to time. The determinations of Cumberland regarding Legal Requirements shall be dispositive for purposes of this Agreement. |
1.8 | Process The practices and procedures to be followed in the manufacturing, labeling, packaging, storage, and transport of the Product, as agreed to by the parties. |
1.9 | Product(s) The final Product(s) that is (are) delivered by Bayer to Cumberland or Cumberlands designee after all Manufacturing Services have been completed by Bayer as specified in Exhibit 1 . Additional Products may be added to Exhibit 1 by mutual written agreement signed by both parties. |
1.10 | Quality Agreement The certain Quality Agreement executed by the parties hereto in connection with this Agreement. |
1.11 | Regulatory Agency A regulatory authority having jurisdiction over the manufacture or sale of a Product. |
1.12 | Specifications The specifications set forth in the Quality Agreement, as may be amended by Cumberland after written notice to Bayer, from time to time. | |
2. | DESCRIPTION OF SERVICES | |
2.1 | Bayer will perform all Manufacturing Services described in the attached Exhibit 1 in accordance with the terms and conditions of this Agreement and the Quality Agreement, as well as in accordance with any manufacturing procedure adopted by written agreement of the parties hereto after production of pilot batches (a Master Batch Record), as applicable, and with all Legal Requirements. Bayer shall perform the Manufacturing Services on a timely basis so as to meet the volume requirements of Cumberland as set forth pursuant to Article 3 below. Without limiting the generality of the foregoing, Cumberland will, at its sole cost and expense, obtain and maintain all Drug Master Files, licenses, permits, certifications, and approvals from any and all Regulatory Agencies which are or may become necessary for the lawful performance of the Manufacturing Services. Bayer shall not make any change whatsoever in the manufacturing facilities, equipment, processes, testing procedures, validation procedures, Specifications, materials or Components, Cumberland Components, or documentation systems used to perform the Manufacturing Services if such change would cause any variation in the quality or merchantability or affect any Regulatory Agency submission, license, permit, certification, or approval required for the performance of the Manufacturing Services, either foreign or domestic, without the prior written consent of Cumberland. | |
2.2 | Bayer shall use commercially reasonable efforts to meet Cumberlands requested delivery dates, which shall be not more than 90 days after Bayers receipt of Cumberlands purchase orders. Requested delivery dates may be changed only by mutual written agreement. In the event that Bayer has reason to believe that it will be unable to meet the agreed upon delivery dates, Bayer will notify Cumberland promptly and state the reason(s) for the delay. |
2.3 | Bayer warrants that all Products delivered to Cumberland or Cumberlands designee pursuant to this Agreement will conform to the Specifications at the time of delivery and will comply with all Legal Requirements in effect at the time of such delivery and shall not be adulterated or misbranded within the meaning of the Act. Bayer agrees to promptly notify Cumberland in writing of any defects in the Products or of any defects as they relate to the manufacture and/or supply of the Products. Bayer shall notify Cumberland and their designee within three (3) business days of learning of any failure of any batch of Products to meet the standards provided by Cumberland pursuant to this Agreement or as otherwise set forth in the Quality Agreement. | |
EXCEPT AS PROVIDED IN THIS SECTION 2.3, BAYER MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE SUPPLY OF THE PRODUCTS, ITS MERCHANTABILITY, OR ITS FITNESS FOR A PATICULAR PURPOSE. BAYER SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES OR LOSS OF ANTICIPATED PROFITS SUSTAINED BY CUMBERLAND. |
2.4 | If Bayer notifies Cumberland of the non-conformance of Products and Bayer is unable to provide Products that conform to the Specifications and comply with all applicable Legal Requirements within ninety (90) days of such notice, contingent on supply of components including new materials, Cumberland may, without limiting any remedies available to it, discontinue the purchase of non-conforming Products from Bayer, without any further obligation to Bayer, and purchase replacement products from an alternate manufacturer until such time as Bayer is able to resume production of Products with Cumberlands approval in accordance with the Specifications and applicable Legal Requirements, subject to depletion of any inventory on hand that was purchased or is to be delivered pursuant to contractual commitments to purchase such Product from the alternate source or sources. In the event Cumberland orders Product from an alternate supplier as provided herein, Bayer shall, at Cumberlands request, provide all reasonable assistance requested by Cumberland to qualify an alternate supplier and supply such alternate supplier with the necessary Active Pharmaceutical Ingredient at Bayers actual manufacturing or acquisition cost. Bayer shall reimburse Cumberland on demand for the difference between the cost of obtaining such substitute Product (plus any commercially reasonable charges, expenses or commissions incurred by Cumberland in connection with effecting cover, and any other reasonable expenses incident to such failure), less the price which would have been due to Bayer for the like quantity of Product if supplied by Bayer hereunder. |
2.5 | Bayer shall obtain and maintain all equipment required to fulfill its obligations under this Agreement consistent with applicable Good Manufacturing Practices. All Products are subject to Cumberlands inspection prior to acceptance. Cumberland shall have fifteen (15) business days following the receipt of Products to inspect the Products for the purposes of rejecting all or a portion of such Products if all or a portion of the Products (i) fails to conform to the Specifications, (ii) shall not have been manufactured in compliance with then applicable Bayer requirements, or (iii) otherwise fails to conform to the warranties set forth in this Agreement; provided, however, that in the event there is a Latent Defect in the Products, Cumberland shall have the right to reject all or a portion of the Products that contain such Latent Defects following discovery thereof, subject to the requirements of Section 2.6 below. Upon detection of any defect, Cumberland shall give notice to Bayer specifying the manner in which all or part of such shipments fails to meet the foregoing requirements and may withhold payment for that shipment or portion thereof which it has rejected. |
2.6 | Upon detection of any material defect, including a Latent Defect, Cumberland shall give notice within three (3) business days to Bayer specifying the manner in which all or part of such shipment fails to meet the foregoing requirements and may withhold payment for that shipment or portion thereof which it has rightfully rejected. Bayer shall have fifteen (15) days within which to cure such defect. In the event that Cumberland rightfully rejects any products |
2.7 | Bayer shall provide all documents and updates with regard to the Product which are required by any Regulatory Agency, and shall submit to all inquiries and inspections by any such Regulatory Agency. All documents provided by Bayer to any Regulatory Agency with regard to the Product shall be provided to Cumberland in advance, if feasible, and in any case within two (2) business days after such documents are provided to any Regulatory Agency. Bayer shall promptly notify Cumberland of all scheduled inspections of Bayers facilities or records by a Regulatory Agency concerning the Product, whereupon Cumberland shall have the right to be present for such inspection. Bayer shall provide any and all written and verbal communications from any Regulatory Agency pertaining to or affecting the Active Pharmaceutical Ingredient or the Product no more than two (2) business days after Bayer receives such communications, including any summary or other record of inspectional observations or findings and all related communications by Bayer with such Regulatory Authority. Cumberland shall have the right to audit Bayers facilities or records during regular business hours on not less than seven (7) days prior written notice by the Cumberland. Such audit shall be limited to facilities and records pertaining to the Product. |
2.8 | Nothing in this Agreement shall prevent Cumberland or its Affiliates from manufacturing Product for amounts in excess of the orders for Product placed with Bayer in accordance with this Agreement. Further, Cumberland or its Affiliates shall not be prevented from qualifying and using sources of supply other than Bayer and securing Manufacturing Services or Product from those other sources, as long as such activities do not interfere with the requirements of this Agreement. In no event, however, shall Bayer disclose to any third party Cumberland Confidential Information (as defined in Article 7 below) belonging to Cumberland, it being understood that any information contained in the Master Batch Record does constitute Confidential Information belonging to Cumberland. | |
3. | SUPPLY OF PRODUCT |
3.1 | Bayer and Cumberland shall cooperate in estimating and scheduling the performance of the Manufacturing Services and the delivery of Product to Cumberland. |
3.2 | Within [***] days after execution of this Agreement and thereafter monthly within [***] days of that respective month, Cumberland shall provide non-binding forecasts for Product to Bayer by month for the immediately succeeding twelve (12) month period. |
3.3 | Cumberland shall issue purchase orders setting forth the quantities and delivery dates at least [***] days in advance of the requested delivery date. Bayer shall be obligated to formulate and supply Product in accordance with quantities and delivery dates requested in the firm orders placed by Cumberland, Bayer will procure sufficient bulk quantities to produce product prior to or at the time a purchase order is issued. |
3.4 | Bayer agrees to give timely notice to Cumberland of any maintenance, plant modifications, or other event that may affect Bayers capacity or otherwise affect its ability to meet forecasted quantities with sufficient advance notice to permit Cumberland to order additional Product to meet its requirements for such periods. Bayer shall use commercially reasonable efforts to assure that adequate capacity is available to fulfill future requirements of Cumberland. |
3.5 | Bayer shall use Cumberland designated carriers. In the event that a Cumberland designated carrier is not available, Bayer may use a qualified carrier of its choice, with prior written approval from Cumberland. Products shall be packed and shipped in accordance with Cumberlands instructions, good commercial practices and in compliance with all Legal Requirements. Each shipment of Product shall be clearly marked as per Cumberlands |
3.6 | Neither Bayer nor any Affiliate thereof will sell, give away, or deleiver to any other person, firm, or corporation any form of Product for indications currently approved as of the Effective Date while this Agreement is effective and for two years after the termination of this Agreement. | |
4. | FEES |
4.1 | In consideration for the services to be performed by Bayer, Cumberland will pay Bayer a fee per unit of Product delivered to and accepted by Cumberland. The quantity and fee per unit to be paid by Cumberland shall be as specified in the attached Exhibit 2 . The quantity and one-time costs to be paid by Cumberland shall be as spedified in the attached Exhibit 1. Regarding definition of Cumberland as described on page 1, responsibility of payment solely resides with Cumberland. | |
4.2 | [***] |
4.3 | In the event of any change in the Specifications requested by Cumberland, Cumberland shall reimburse Bayer for costs actually incurred by Bayer in connection with such change, including without limitation, one-time development costs specifically related to such change, costs of obsolescence of raw materials, goods-in-process, packaging material components and supplies (bulk containers and labels), and finished goods, which shall be valued at the cost incurred by Bayer, except that finished goods inventory will be valued at the Price pursuant to Exhibit 2 of this Agreement. |
4.4 | All fees shall be determined on the basis of Product being delivered F.O.B. Cumberlands third party packager [plant location] and may be subject to change by mutual agreement of the parties hereto after the third anniversary of the Effective Date. |
4.5 | Fees payable by Cumberland to Bayer under this Agreement shall be due and payable [***] days after the receipt of Bayers invoice and all required accompanying documentation to be supplied by Bayer and acceptance of the delivered Product by Cumberland. If Cumberland does not timely issue a notice of non-conformity of the delivered Product to Bayer pursuant to the Quality Agreement, such delivered Product shall be considered accepted by Cumberland. Bayer will issue its invoice only at such time as Product |
5. | ADVERSE EVENTS/RECALLS/WITHDRAWALS | |
5.1 | Bayer shall inform Cumberland immediately of any important information relating to the activity, side effects, toxicity, and/or safety of the Product that becomes known to Bayer during the term of this Agreement. Furthermore, Bayer shall inform Cumberland immediately of any defects in the manufacturing processes for the Product that becomes known to Bayer during the term of this Agreement. Bayer agrees to carry out its obligations with respect to the reporting of adverse drug reactions as described in the attached Exhibit 3 . |
5.2 | Cumberland shall inform Bayer immediately of any important information relating to the activity, side effects, toxicity, and/or safety of the Product that becomes known to Cumberland during the term of this Agreement and that is relevant to the performance of the Manufacturing Services by Bayer. Cumberland agrees to carry out its obligation with respect to the reporting of adverse drug reactions as described in the attached Exhibit 3 . |
5.3 | In the event that a recall or market withdrawal of a Product is required by a governmental agency or authority of competent jurisdiction, or if a recall or market withdrawal of Product is deemed advisable by Cumberland in its sole discretion, such recall shall be implemented and administered in a manner which is appropriate and reasonable under the circumstances and in conformity with any requests or orders of local Regulatory Agencies, as well as accepted trade practices. The costs and expenses associated with the recalling or withdrawing a Product shall be paid by Cumberland, provided, however, that if the recall or withdrawal is related to a failure of Bayer to follow the Specifications or to any act or omission of Bayer in its performance of the Manufacturing Services, the costs of the recall solely related to Bayers failure in performance shall be borne by Bayer. In the event that a Product is recalled or that Cumberland is required to disseminate information relating to a Product covered by this Agreement, Cumberland shall so notify Bayer within a reasonable time so as to enable Bayer to provide Cumberland with such assistance in connection with such recall as may reasonably be requested by Cumberland. Bayer will comply with all such reasonable requests from Cumberland. Cumberland shall handle exclusively the organization and implementation of all recalls of the Product. | |
6. | INDEMNIFICATION | |
6.1 | Bayer shall indemnify, defend and hold Cumberland, its Affiliates, and their respective principals, directors, officers, employees, representatives and agents harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys and consultants fees and amounts paid in settlement with the consent of Bayer, which consent shall not be unreasonably withheld or delayed) arising from any claim, lawsuit, or other action made, brought, or threatened against Cumberland as a result of (i) a breach or default of this Agreement or the Quality Agreement by Bayer, or (ii) any act or omission by Bayer in the performance of the Manufacturing Services, except to the extent such claim, lawsuit, or other action results from any act or omission by Cumberland relating to its performance of this Agreement. Cumberland shall inform Bayer of any such claim, lawsuit, or other action to which this Paragraph 6.1 applies within a reasonable time after receiving notice thereof. Cumberland shall have the right to retain, at its own expense, its own legal counsel to defend it with respect to such claim, lawsuit, or other action and to participate in the defense thereof, provided, however, that to the extent Bayer is obligated to indemnify Cumberland, Bayer shall have control of the defense of the action. |
6.2 | Cumberland shall indemnify, defend and hold Bayer, its Affiliates, and their respective principals, directors, officers, employees, representatives and agents harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable |
6.3 | Bayer or Cumberland, as the case may be, will respond to all reasonable requests from the other to assist in the disposition of any claim, lawsuit, or other action to which Paragraphs 6.1 and/or 6.2 apply. |
6.4 | Title and risk of loss to the the in-process and released Product shall remain with Bayer while such Product is in the possession of Bayer. | |
7. | CONFIDENTIALITY |
7.1 | Each party may from time to time provide to the other party information (hereinafter Confidential Information). For purposes of this Agreement, Confidential Information shall not include: |
a. | information which was known to the receiving party prior to receipt from the disclosing party, as evidenced by written records; | ||
b. | information which was in the public domain or generally known to the trade at the time of receipt from the disclosing party; | ||
c. | information which enters the public domain or becomes generally known to the trade through no fault of the receiving party; | ||
d. | information which is disclosed to the receiving party by a third party who is not under an obligation of confidentiality to the disclosing party; | ||
e. | information which is independently developed by the receiving party without use of the disclosing partys Confidential Information, as evidenced by written records; or | ||
f. | information which is required to be disclosed by law, regulatory, administrative or judicial order, provide that the receiving party has provided the disclosing party with sufficient advance notice or such disclosure to enable the disclosing party to seek to restrict the public disclosure of such Confidential Information. |
7.2 | Each partys Confidential Information shall be kept confidential by the other party and shall not be disclosed by such other party for a period that is five (5) years from the expiration or termination of this Agreement. Such Confidential Information shall not be disclosed by such other party other than to its officers, employees, and agents who are engaged in its operations relating to the Product and who have the need to know such Confidential Information for purposes of meeting its obligations under this Agreement and the Quality Agreement. The receiving party will only use Confidential Information of the disclosing party in the furtherance of the purposes of this Agreement. Either party may use a disclosers Confidential Information for the purpose of obtaining and maintaining approvals of a Regulatory Agency or to otherwise meet Legal Requirements with respect to Product. Notwithstanding the foregoing, Confidential Information may be disclosed if it is required to be disclosed in compliance withapplicable laws or regulations, subpoena, court order, or order of such other governmental or regulatory agency having competent jurisdiction; or either party reasonably believes that it is necessary to disclose Confidential Information in connection with any action, suit, or proceeding before any court or any governmental or other |
7.3 | All new techniques, discoveries, inventions, processes, and know-how (each a New Development) relating to the Product which are developed by Bayer during the performance of this Agreement and which result from access to Cumberland or its Affiliates Confidential Information shall be the property of Cumberland or its Affiliates. Cumberland or its Affiliates shall grant to Bayer a nontransferable, nonexclusive, royalty-free, worldwide, perpetual license to make, use, sell, and offer to sell such New Development(s). This licensing shall expire upon termination of this agreement. Notwithstanding the grant of such license, Bayer shall not use such New Development(s) of Cumberland or its Affiliates Confidential Information to compete, or assist third parties in competing, directly or indirectly, with Cumberland or its Affiliates in the use or sale of the Product Bayer agrees to cooperate in the filing and prosecution of all New Development(s) patent applications filed by Cumberland or its Affiliates, but Cumberland or its Affiliates shall bear all associated expenses. As to New Development(s) which may be developed by Bayer during the performance of this Agreement which relate to the Product but which do not result from access to Confidential Information of Cumberland or its Affiliates, Bayer grants to Cumberland or its Affiliates a nontransferable, royalty-free, irrevocable, worldwide, nonexclusive license to make, have made, sell, or offer to sell the New Development(s) in connection with the Product. |
7.4 | Neither party shall use the others name or refer to it directly or indirectly in an advertisement, news release, or release to any professional or trade publication without written approval from such party. The parties expressly consent to such disclosure in filings with the Securities and Exchange Commission and the Food and Drug Administration and analogous agencies in other countries. Cumberland or its Affiliates and Bayer agree that the existence and contents of this Agreement shall be maintained in confidence and not disclosed or used for any purpose without the prior written consent of each party, except as otherwise provided herein or required by law. | |
7.5 | The provisions of this Article 7 shall survive termination of this Agreement for any reason. | |
8. | TERM | |
8.1 | This Agreement shall become effective on the Effective Date and, except as otherwise provided herein, shall be in effect for an initial term of [***] years. Thereafter, so long as this Agreement is in force, it shall be automatically renewed for additional terms of one (1) year, unless one party elects to terminate this Agreement by notice thereof to the other party in writing at least six (6) months prior to expiration of the then existing term. |
8.2 | Either party may terminate this Agreement for a material breach by the other party by giving the breaching party written notice, specifying the breach relied on, and giving the breaching party thirty (30) days to cure such breach. If the breaching party has not cured the default at the end of the thirty (30) day period, then, upon notice thereof to the breaching party by the other, this Agreement shall terminate. Termination for breach will have no effect on obligations that have accrued up to the effective date of such termination or any obligations that, by their terms, survive the termination of this Agreement. |
8.3 | Cumberland shall have the right to terminate this Agreement upon thirty (30) days notice in the event of a change of the site of manufacture of any Products to any site that has not been approved by Cumberland. Such approval shall not be unreasonably withheld. | |
8.4 | Cumberland may terminate this Agreement in the event of a change in control of Bayer. A |
8.5 | In the event of any proceedings, voluntary or involuntary, in bankruptcy or insolvency, by or against Cumberland or Bayer, or the appointment with or without the partys consent of a receiver for either party, or the other party makes or seeks to make a general assignment for the benefit of its creditors or applies for or consents to the appointment of a trustee or custodian for it or a substantial part of its property, and such situation is not cured within thirty (30) days from its occurrence, the other party shall be entitled to terminate this Agreement upon giving written notice. |
8.6 | In the event of termination pursuant to this Section 8, the parties will cooperate in the orderly transition of supply so as not to cause inconvenience to either party. Should termination in accordance with this section 8 be initiated by Bayer, Bayer shall notify Cumberland in writing of its desire to so terminate; provided, however, that termination by Bayer shall not be effective until Cumberland has located and arranged for continuation of any ongoing Manufacturing Services with another product manufacturer, so long as such termination procedure shall not extend beyond eighteen (18) months from Bayers written notice of termination to Cumberland. In the event Bayer terminates this Agreement as provided hereunder, Bayer shall, at Cumberlands request, provide commercially reasonable assistance requested by Cumberland to qualify an alternate supplier. The parties will cooperate during such period to continue the Manufacturing Services on the basis set forth in this Agreement. In the event of notice of such early termination by Cumberland, Bayer shall perform such functions reasonably necessary or required in connection with the orderly wind-down of the Manufacturing Services as required by the terms of this Agreement and/or any Legal Requirements, including any applicable Regulatory Agency regulations, and Cumberland shall pay Bayer for the Manufacturing Services performed, under the terms and conditions of this Agreement. |
8.7 | Cumberland shall also have the right to terminate this Agreement upon thirty (30) days written notice to Bayer in the event a Regulatory Agency does not approve the Product for marketing; or a Regulatory Agency withdraws marketing approval; or Cumberland otherwise terminates the commercial sale of Product. If Cumberland terminates pursuant to this provision or a Regulatory Agency does not approve the Product for marketing or withdraws marketing approval, Cumberland shall reimburse Bayer for any purchases of Components used in the performance of the Manufacturing Services which cannot be cancelled, as well as associated documented out-of-pocket costs incurred by Bayer in performances of Manufacturing Services. The reimbursement shall be made within thirty (30) days following receipt by Cumberland of an invoice itemizing the costs of such Components and Manufacturing Services. Bayer agrees to transfer to Cumberland any Components paid for by Cumberland under this provision. Termination under this provision shall have no effect on payment obligations that otherwise may have accrued up to the effective date of termination. | |
9. | COMPLIANCE WITH APPLICABLE LAW |
9.1 | During the term of this Agreement, Bayer and all its subcontractors, employees, agents, representatives, and invitees shall comply with all applicable laws, governmental regulations, rules, requirements, ordinances, and other requirements of federal, state, and local authorities. Bayer is not authorized to take any action in the name of or otherwise on behalf of Cumberland which would violate any of the foregoing. |
9.2 | Bayer represents and warrants that at the time of submission of its proposal for the performance of the Services, it was and remains properly licensed and qualified to do business in all jurisdictions in which the Services are to be performed, and agrees that it will maintain such licenses and qualifications and acquire any additional licenses and |
9.3 | Bayer represents and warrants that it has not and has never been, nor has any of its employees, agents, or subcontractors who may provide services under this Agreement ever been debarred or, to the best of its knowledge, (i) convicted of a crime for which a person or entity can be debarred, under Section 306(a) or 306(b) of the United States Generic Drug Enforcement Act of 1992 or under 42 USC Section 1320a-7, or (ii) sanctioned by, suspended, excluded, or otherwise ineligible to participate in any federal health care program, including Medicare and Medicaid, or in any federal procurement or non-procurement programs. | |
9.4 | Bayer agrees: |
a. | to comply with the equal employment opportunity and affirmative action provision of: (1) Executive Order 11246, as amended and U.S. Dept. of Labor regulations issued pursuant thereto (41 CFR 60); (2) Section 503 of the Rehabilitation Act of 1973 (29 U.S.C. 793), as amended; and U.S. Dept. of Labor regulation issued pursuant thereto (41 CFR 60-741), in contracts for $2500 or more; and (3) Section 402 of the Vietnam Era Veterans Readjustment Assistance Act of 1974 (38 U.S.C. 2012), and U.S. Dept. of Labor regulations pursuant thereto (41 CFR 60-250), in contracts for $10,000 or more; Title VII of Civil Rights of 1964, 78 Stat. 253, as amended, and regulations issued pursuant thereto. |
10. | INSURANCE |
a. | Each Party shall obtain and maintain insurance coverage against such liability in limits provided in Exhibit 4 . Each Party stipulates that it will use its best efforts such that the insurance will not be cancelled while this Agreement is in effect without thirty (30) days prior written notice to the other Party. Each Party shall maintain such insurance during the Term and thereafter for so long as it customarily maintains insurance for itself for similar products and activities. Each Party shall use its best efforts so that the other Party is named as an additional insured under the Product Liability policy and shall provide the other Party proof of such insurance upon request. Each party shall use its best efforts to provide reasonable notice to the Party listed as additional insured on its Product Liability Policy of any cancellation, termination, or change in such insurance, such prior written notice to be no less than thirty (30) days of any such change. Each Party shall obtain and maintain product liability insurance coverage against such liability in limits provided in Exhibit 4 . Each Party stipulates that the insurance will not be cancelled while this Agreement is in effect without thirty (30) days prior written notice to the other Party. |
11. | MISCELLANEOUS | |
11.1 | Except as provided in Paragraph 7.3, nothing in this Agreement will be deemed or construed as providing either party any right, title, interest, or license in or under any intellectual property right owned or controlled by the other party. | |
11.2 | Modifications and amendments to this Agreement and its Exhibits require the written consent of both parties. | |
11.3 | No waiver of any requirement of this Agreement, whether by conduct or otherwise, will be effective unless in writing. The waiver in any one or more instances will not be deemed or construed to be a further or continuing waiver of any such requirement or of any other requirement of this Agreement. | |
11.4 | The provisions of this Agreement shall be deemed separate. Accordingly, the invalidity, illegality, or unenforceability of any particular provision of this Agreement shall not in any way affect or impair the other provisions, and this Agreement shall be construed in all respects as if such invalid, illegal, or unenforceable provision were omitted, except in cases where such unenforceable provision is a basic requirement of any party or both parties to |
11.5 | Any notice required or permitted to be given hereunder will be deemed sufficient if delivered by hand or sent by overnight courier to the parties at the addresses set forth below, or such other addresses as either party may designate. Notice will be deemed given when received. |
11.6 | Neither party will assign this Agreement, or subcontract any of its obligations hereunder, to any other person or entity other than to one or more Affiliates, without the prior written consent of the other party, which consent will not be unreasonably withheld; however, in the event of any assignment or subcontract, the party effecting such assignment or subcontract shall guarantee the performance of the assignee or subcontractor in a form satisfactory to the other party. Notwithstanding the foregoing, either party may, without such written consent, assign this Agreement, and its rights and objections hereunder, in connection with the transfer or sale of all or substantially all of its business or part of its business to which this Agreement pertains, or in the event of its merger or consolidation or change in control or similar transaction, provided the permitted assignee shall have assumed all obligations of the assignor under this Agreement. |
11.7 | This Agreement will be binding upon and inure to the benefit of the permitted successors or permitted assigns of Bayer and Cumberland. | |
11.8 | This Agreement shall be construed, interpreted, and applied in accordance with the laws of the State of New York ,without reference to it conflict of laws provisions. |
11.9 | Product labeling (primary, secondary, and insert) and filings with a Regulatory Agency may indicate that the Product has been manufactured for Cumberland by Bayer. Except when Legal Requirements mandate or when necessary to seek the approval of any Regulatory Agency, |
11.10 | If either of Bayer or Cumberland is impeded in fulfilling its undertakings in accordance with this Agreement due to any cause beyond the reasonable control of Bayer or Cumberland, as the case may be, such as, but not limited to fires, flood, earthquakes, lightening strike, acts of God, catastrophic accident, terrorism, war, mobilization or unforeseen military call-up of a large magnitude, requisition, confiscation, commandeering, public decrees, acts, restraints, regulations or directions of governmental authorities, riots, insurrections, general shortage of transport, goods, or energy and faults or delays in deliveries from subcontractor or supplier caused by any circumstances referred to in this Paragraph 11.10, the impediment shall be considered a Force Majeure, and the party shall be exempted from liability for delays due to such reasons, provided always that it notified the other party thereof without undue delay after such a circumstance has occurred. Upon such notification, Bayer and Cumberland shall agree upon a reasonable extension of the delivery time, not to exceed two (2) months. If, after two (2) months following notification of the Force Majeure condition, such condition persists, Cumberland may cancel the purchase orders affected by the Force Majeure condition. Notwithstanding any of the foregoing, if any extension of the delivery time causes hardship to Cumberland in the maintenance of its business, Cumberland may purchase its Products requirements during such extension period from a third party as provided above. |
11.11 | Neither party shall have the right to control the activities of the other in the performance of this Agreement, and each shall perform as an independent contractor, and nothing herein shall be construed to be inconsistent with that relationship or status. Under no circumstances shall the employees or agents of one party be considered employees or agents of the other. This Agreement shall not constitute, create, or in any way be interpreted as a joint venture, partnership, or formal business organization of any kind. |
11.12 | This Agreement, together with its attached Exhibits and the Quality Agreement and the Services Agreement dated February 6, 2008, constitutes the entire agreement between Bayer and Cumberland with respect to the Manufacturing Services to be performed by Bayer. The requirements of this Agreement supersede all prior understandings and agreements, whether oral or written, all terms and conditions contained within any purchase order, acknowledgement, invoice, or other agreement between Bayer and Cumberland with respect to the Manufacturing Services. Other terms and conditions not inconsistent with the terms and conditions of this Agreement covering Products to be supplied under this Agreement will be provided in purchase orders and releases issued by Cumberland and in order acknowledgements and invoices issued by Bayer. In the event of a conflict between the terms and conditions of any of these documents, including the Quality Agreement, Bayer and Cumberland agree to negotiate in good faith to resolve such differences, unless such terms conflict with the terms of this Agreement, in which case the terms of this Agreement shall control. |
11.13 | Bayer and Cumberland covenant and agree that subsequent to the execution and delivery of this Agreement and without any additional consideration, each of Bayer and Cumberland shall execute and deliver any further legal instruments and perform such acts which are or may become necessary to effectuate the purposes of this Agreement. |
11.14 | Bayer and Cumberland agree to use their best efforts to resolve any and all disputes arising out of or relating to this Agreement. If after thirty (30) days following receipt of notice by one party from the other of a dispute under this Agreement, the parties are unable to resolve the dispute, then the matter shall be fully and finally resolved in a court of law. |
11.15 | The heading of the Articles and Paragraphs used in this Agreement are included for convenience only and are not to be used in construing or interpreting this Agreement. |
11.16 | This Agreement may be executed in any number of counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Bayer and Cumberland may rely upon facsimile signatures as binding execution of this Agreement and the instruments contemplated hereby. Each of Bayer and Cumberland shall promptly send originally executed versions of any documents or instruments bearing facsimile signatures to the other party |
| Bayer to perform necessary scale up/engineering batch, demonstration batching to move product to commercial manufacturing. | ||
| Bayer to source all materials required to perform scale up/product transfer and begin to qualify all excipient materials. | ||
| Cumberland to provide and Bayer to transfer lab methods required to support scale up and engineering batch production and cleaning validation. | ||
| Bayer to produce Cumberland recommended and mutually agreed upon amount and scale of validation batches and prepare specified number of stability samples (if required). | ||
| Bayer to develop validation documents and circulate for Cumberland approval and execute protocols. | ||
| Bayer to develop stability program protocols (if required), circulate for Cumberland approval and execute protocols. | ||
| Bayer to prepare final reports for validation and stability activities and provide to Cumberland for inclusion in the regulatory submission, as appropriate. | ||
| Cumberland will advise if any tight container testing is required. Bayer may develop the protocols, for a fee, and perform that testing. | ||
| Cumberland will decide and perform any leechable or extractable testing required for in-process or finish product containers. |
| Based on issuance of a purchase order by Company, manufacture commercial batch quantities of Product. | ||
| Develop material specifications for all materials, identify suppliers of materials, procure materials and manage material inventory levels (based on forecasts). | ||
| Using transferred laboratory methods for product engineering batch production/scale up activities perform incoming material testing, in-process testing and final release testing. Based on this testing a certificate of analysis will be issued, along with copy of batch records, to Cumberland on a per batch basis. | ||
| Per batch, retained samples will be maintained and held by Bayer. | ||
| Develop ongoing sampling protocols for stability program and maintain samples (if required) | ||
| Maintain waste material and Health and Environmental Saftey (HES) reporting for ongoing production requirements. |
| Provide Cumberland audit access to manufacturing area and documents related to the production of their product(s). | ||
| Ship lot quantities of finished and released vials to Cumberland, single point location. Shipment will be FOB Shawnee, KS using the carrier/method of choice from Cumberland. |
| Assistance in the recommendation for the components or facilitate the actual submission of regulatory documents. | ||
| Assume the commercial viability of this formulation and/or packaging configuration of this product in the marketplace, except as otherwise set forth in the Manufacturing Agreement. | ||
| Performance/assurance of the product regarding scalability. Cumberland is requested to be present, support and approve all follow up Bayer scale up activities and share in accepted performance (and costs) of the product during those scale up activities. | ||
| Assure the accuracy/reliability of original laboratory methods. | ||
| Support or make claims about the placement of this product in the marketplace. |
Cumberland Pharmaceuticals, Inc.
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One Time Costs Ibuprofen Inj
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1.0 | Commercial General Liability Insurance: |
2.0 | Workers Compensation |
3.0 | Product Liability |
4.1 | All policies, other than for Product Liability, shall be issued on an occurrence basis unless such coverage is not available on commercially reasonable terms. Where insurance is on a Claims Made basis, each Party shall maintain the coverage until the later of the expiration of three years after the manufacture of the final batch of Product by Bayer or of all applicable statutes of limitations. Each Party shall list the other Party as an additional insured. |
4.2 | The Product Liability policy shall be issued on a Claims Made basis. Each Party shall maintain the Product Liability coverage until the later of the expiration of three years after the manufacture of the final batch of Product by Bayer or the applicable statute of limitations. |
4.3 | Bayer reserves the right to self-insure for any and all coverages. |