5000 LITER SCALE MULTI- PRODUCT SUPPLY AGREEMENT

Supply Agreement

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IMCLONE SYSTEMS INC | LONZA BIOLOGICS PLC

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Title: 5000 LITER SCALE MULTI- PRODUCT SUPPLY AGREEMENT
Date: 5/10/2005
Industry: Biotechnology and Drugs Law Firm: Lonza Biologics plc Sector: Healthcare

Exhibit 10.30

5000 LITER SCALE MULTI- PRODUCT SUPPLY AGREEMENT

between

LONZA BIOLOGICS PLC

and

IMCLONE SYSTEMS INCORPORATED

TABLE OF CONTENTS

ARTICLE		TITLE

1		Definitions

2		Term

3		Supply by ImClone

4		Agreement to Supply

5		Order Quantities and Ordering Procedures

6		Provision of the Services

7		Delivery and Transportation of Products; ImClone Tests

8		Steering Committee

9		Process Changes

10		Shared Manufacturing

11		Regulatory Support and Quality Assurance

12		Excess Capacity

13		Price and Terms of Payment

14		Warranties, Limitation of Liabilities, etc.

15		Limitations of Liability

16		ImClone Information, LB Information and Patent Rights

17		Termination

18		Force Majeure

19		Governing Law, Jurisdiction and Enforceability

20		Miscellaneous

[*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

ATTACHMENTS

Attachment 1 — Final Product Specifications
Attachment 2 — Tech Transfer

This Multi- Product SUPPLY AGREEMENT, dated as of March 17, 2005, is by and between LONZA BIOLOGICS PLC, an English corporation (“LB”), of 228 Bath Road, Slough, Berkshire SL1 4DX, England, and IMCLONE SYSTEMS INCORPORATED, a Delaware corporation (“ImClone”), of 180 Varick Street, New York, NY 10014.

W I T N E S S E T H :

WHEREAS, LB has available manufacturing capacity in the 5000 liter scale; and

WHEREAS, ImClone has desire to utilize said existing capacity;

NOW, THEREFORE, the parties hereto agree as follows:

1. Definitions .

1.1. In this Agreement, the following terms have the meanings set forth below:

1.1.1. “Affiliate” means any corporation, partnership, limited liability company or other entity, which directly or indirectly controls, is controlled by or is under common control with the relevant party to this Agreement, and “control” and its correlates means the ownership of more than fifty percent (50%) of the issued voting shares, or the legal power to direct or cause the direction of the general management and policies, of the party in question.

1.1.2. “Agreement” means this Product Supply Agreement between LB and ImClone.

1.1.3. “Batch” means the quantity of total bulk purified Product (including samples taken during the 5000 Liter Process) which is produced as a result of the completion of one operation of the 5000 Liter Process for the

Product in the 5000 Liter Manufacturing Suite in accordance with the Specifications and with cGMP.

1.1.4. “Batch Price” means the sum which is payable to LB for the performance of the Services with respect to a Batch as determined pursuant to Article 13 hereto, which fee compensates LB for, among other things:

(i) storage of the cell banks of the Cell Line during the term of this Agreement;

(ii) preparation and maintenance of manufacturing documents for the manufacture of bulk Product;

(iii) performance of the cell culture phase of the 5000 Liter Process;

(iv) performance of the purification phase of the 5000 Liter Process;

(v) analysis of Product according to the Specifications;

(vi) review of completed Batch records; and

(vii) the costs of operating the 5000 Liter Manufacturing Suite (including but not limited to the use and operation of all equipment and supply of utilities);

(viii) the costs of all raw materials excluding purification resins, are included in the Batch Price set forth in Section 13.1.1.Purifcation resins shall be charged at cost to ImClone.

1.1.5. This Section left intentionally blank.

1.1.6. “Cell Line” means the cell line used in the manufacture of the Product then being produced, as the same may be amended from time to time in accordance with the provisions of this Agreement.

1.1.7. “Certificate of Analysis” means a document certifying that LB has performed certain tests specified and agreed to by both parties on each Batch of Product and containing the results of those tests and whether or not the Batch of such Product meets agreed upon specifications; and certifying that the Batch of such Product was manufactured in accordance with the approved process.

1.1.8. “cGMP” means current Good Manufacturing Practices as promulgated under and in accordance with ICH Q7A GMP guidelines and the U.S. Federal Food, Drug and Cosmetic Act, 21CFR (Parts 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC, as appropriate.

1.1.9. This Section left intentionally blank.

1.1.10. “Deliver” or “Delivery” has the meaning ascribed to it in Section 7.1.

1.1.11. “Delivery Date” means, with respect to a particular Batch, the date of issuance of a Certificate of Analysis by LB or the date on which a given Batch of Product, conforming to the Specifications, is made available for Delivery to ImClone, EXW (ex-works) LB (NH)’s premises, whichever is later.

1.1.12. “Effective Date” means the date of this Agreement set forth in page 1.

1.1.13. “Fermenter Train” means two seed reactors (50L and 500L) and the production reactor (5000L).

1.1.14. This Section left intentionally blank.

1.1.15. “ImClone Information” means all know-how, technical information and other information known to, controlled by or owned by ImClone or its Affiliates from time to time and not known to and at the free disposal of LB prior to its disclosure by ImClone to LB or LB (NH) or their respective Affiliates and not freely available in the public domain including, without limitation, the Cell Line, the 5000 Liter Process, and the Product.

1.1.16. “ImClone Materials” means the materials supplied or to be supplied by ImClone to LB or LB (NH) or their respective Affiliates pursuant to Article 3 or supplied pursuant to previous Services Agreements between the parties. ImClone Materials shall include the Cell Line and purification resins. ImClone shall have and shall retain all rights to ImClone Materials except as specifically provided in Section 3.3.

1.1.17. “ImClone Patent Rights” means all Patent Rights that are owned by or licensed to ImClone from time to time during the term hereof.

1.1.18. “ImClone Tests” means the tests that both parties have agreed will be carried out on the Product following its receipt by ImClone, as modified from time to time by written agreement between the parties.

1.1.19. This Section left intentionally blank.

1.1.20. “5000 Liter Manufacturing Suite” means the 5000 Liter cGMP manufacturing facility located at the LB (NH) Portsmouth, New Hampshire manufacturing site, which shall include two 5000 Liter (5000L) airlift fermenter and associated seed trains, harvest and purification equipment.

1.1.21. “5000 Liter Process” means the process for the production of the Product from the Cell Line, as such process is transferred from ImClone to LB under an appropriate Technology Transfer Agreement between the parties.

1.1.22. “Product” means any product made from a cell line and process which are compatible with manufacture in the 5000 Liter Manufacturing Suite including the monoclonal antibody known as ERBITUX â (cetuximab and formerly known as IMC-C225) (including any sample thereof). ImClone shall notify LB of any change in the identity or formulation of the then-current Product no later than six (6) months before the commencement of manufacture. Notwithstanding the foregoing, the Parties understand that any Product to be manufactured in the 5000 Liter manufacturing suite must have a process similar to the production Process for ERBITUX â , (i.e. similar fermentation time in the production reactor and a similar purification time.). If the production process requires more fermentation time or additional purification time the Batch Price for the Product will be adjusted accordingly. ImClone shall notify LB of the Product and any substitute product no later than six (6) months before the commencement of manufacture. Before commencement of the campaigns particulars of the Product will be set out in Attachments to this Agreement as amended from time to time in accordance with this Agreement or any new formulation of such antibody.

1.1.23. “LB (NH)” means LB’s Affiliate, Lonza Biologics, Inc. of Portsmouth, New Hampshire.

1.1.24. “LB Information” means all know-how, technical information and other information known to, owned by or controlled by LB or its Affiliates from time to time, and not known to and at the free disposal of ImClone prior to its disclosure by LB to ImClone and not freely available in the public domain.

1.1.25. “LB Patent Rights” means all Patent Rights of which LB or any of its Affiliates is from time to time the owner during the term hereof.

1.1.26. “Out of Freeze” shall mean the date that the vial of Product cells is thawed to start manufacture of a Batch.

1.1.27. This Section left intentionally blank.

1.1.28. This Section left intentionally blank.

1.1.29. This Section left intentionally blank.

1.1.30. “Minimum Order” shall mean ***** Batches of the Product or, if a substitute product is used, such batch quantity as reasonably determined by the Steering Committee.

1.1.31. “Patent Rights” means all patents and patent applications owned or licensed of any kind throughout the world, including without limitation all substitutions, extensions, reissues, renewals, and inventor certificates, and patents issuing from applications (including provisionals, divisionals, continuations and continuations in part).

1.1.32. “Presidents” has the meaning ascribed to it in Section 8.3.

1.1.33. This Section left intentionally blank.

1.1.34. “Producer Price Index” or “PPI” means the Producer Price Index for Pharmaceutical Prescription Preparations, Prescription (“PPI” Series ID PCU 325412325412, as reported by the Bureau of Labor Statistics of the U.S. Department of Labor or, if such index is no longer available, such index by which it is replaced by the Bureau of Labor Statistics or any successor U.S. agency issuing such indices. If such index is discontinued and there is no direct successor index, the Steering Committee shall designate an appropriate index that approximates as closely as possible such Bureau of Labor Statistics index.

1.1.35. “Raw Materials” means all materials, and supplies, which are purchased or used by LB in the performance of the Services.

1.1.36. This Section left intentionally blank.

1.1.37. “Services” means the services to be provided by LB which are the subject of this Agreement, including without limitation, the services described in Article 4 below and the provision of personnel and operation of relevant plant and equipment to accomplish those services.

1.1.38. This Section left intentionally blank.

1.1.39. “Specifications” means the specifications for each Product, as established before commencement of any campaign by ImClone and confirmed through designated batches as mutually agreed between Parties which specifications may be modified from time to time pursuant to Section 9.

1.1.40. “Steering Committee” means the committee established pursuant to Section 8.1.

1.1.41. “Testing Laboratories” means any third party instructed by LB to carry out tests on the ImClone Materials or the Product.

1.2. Unless the context requires otherwise, references to the singular include the plural and vice versa, references to Attachments are references to attachments to this Agreement, and references to Articles and Sections are references to the articles and sections of this Agreement.

2. Term .

2.1. This Agreement shall take effect as of the Effective Date and shall remain in effect until the delivery of the ***** batch, unless earlier terminated as provided for in Section 2.2 below or Article 16 or extended under an amendment to this Agreement.

2.2 Not withstanding any terms in this Agreement to the contrary, the parties agree, that ImClone may terminate this Agreement upon six (6) months prior written notice, without any financial penalty, at any time after the completion of the Minimum Order.

3. Supply by ImClone .

3.1. Supply of Cell Line and Reference standard . ImClone shall supply or cause to be supplied, sufficient purified reference standard for the Product and sufficient ampoules of the Cell Line from an appropriate cell bank for LB to provide the Services.

3.2. Supply of other ImClone Materials . ImClone shall ensure the adequate and timely supply of further amounts of the ImClone Materials in sufficient quantity to facilitate LB’s performance of the Services. LB must provide ImClone timely notice, in writing, of its requirements for ImClone Materials.

3.3. Rights in ImClone Information, ImClone Patent Rights and ImClone Materials . ImClone hereby grants LB the non-exclusive right to use the ImClone Information, the ImClone Patent Rights and the ImClone Materials solely for the purpose of LB performing Services for ImClone under this Agreement. Without prejudice to any other rights vested in LB pursuant to pre-existing or future agreements between the parties or their Affiliates, LB will not use the ImClone Information, ImClone Patent Rights or ImClone Materials (or any part thereof) for any other purpose without ImClone’s prior written consent. Except as set forth in this Section 3.3, no licenses are granted to LB to use the ImClone Materials, the ImClone Patent Rights or the ImClone Information, and no licenses shall arise or be deemed to have arisen by default, estoppel or otherwise.

3.4. LB Obligations regarding ImClone Materials . LB shall:

3.4.1. At all times use all reasonable endeavors to keep the ImClone Materials and Raw Materials secure and safe from loss and damage in such manner as LB stores its own materials of similar nature;

3.4.2. Not part with possession of the ImClone Materials or the Product, save for the purpose of tests at the Testing Laboratories or as directed by ImClone; and

3.4.3. Cause all Testing Laboratories to be subject to confidentiality and limited-use obligations no less onerous than those confidentiality and limited-use obligations imposed on LB under this Agreement.

3.5. No Other License . Without prejudice to LB’s right to receive payment of the Price hereunder or to LB’s own proprietary rights in the LB Information and the LB Patent Rights, LB agrees that, except as expressly provided in Section 3.3 above, LB shall not by virtue

of this Agreement acquire any right, license or title in, or to, the ImClone Patent Rights, the ImClone Information, the ImClone Materials, the 5000 Liter Process, or the Product.

3.6. ImClone Representations and Warranties . Provided that the Product is IMC-C225, then ImClone represents and warrants to LB as follows: (If a different product is to be produced, ImClone agrees to make new representations and warranties regarding such product and both parties agree to negotiate in good faith such new representations and warranties with the goal that such new representations and warranties will satisfy, whenever practicable, the intent of this Section 3.6.)

3.6.1. ImClone has the corporate power and authority to enter into this Agreement;

3.6.2. To the best of ImClone’s knowledge and belief, ImClone has, and subject to Section 3.6.5 below, shall at all times throughout the term of this Agreement have, the right to supply the Cell Line, the other ImClone Materials and the ImClone Information to LB;

3.6.3. Any of the Cell Line, the other ImClone Materials, ImClone Information and ImClone Patent Rights not owned by ImClone are licensed to ImClone under a license which will permit their use by LB to perform the Services;

3.6.4. To the best of ImClone’s knowledge and belief, the use by LB of the Cell Line, other ImClone Materials, ImClone Information, ImClone Patent Rights and the Large Scale Process (excluding any steps made or developed by LB) for the Services will not infringe any rights (including, without limitation, any intellectual property rights) of any third party; and

3.6.5. Except as to alleged infringement actions disclosed on Schedule 3.6, ImClone will promptly notify LB in writing if it is no longer entitled to supply the Cell Line, other ImClone Materials, ImClone Information or the ImClone Patents for the Services or if ImClone is aware that the use thereof infringes or is alleged to infringe any rights (including, without limitation, any intellectual property rights) of any third party.

3.6.6. To ImClone’s knowledge, ImClone has disclosed, and shall disclose, to LB all environmental requirements that ImClone is aware of or becomes aware of, without independent investigation by ImClone, which LB must comply with during the use of the 5000 Liter Process (excluding any steps made or developed by LB).

3.7. ImClone IP Indemnification . ImClone will indemnify, defend and hold harmless LB and its Affiliates against any loss, damage, costs and expenses of any nature (including reasonable fees and disbursements of counsel and experts) incurred by LB or any Affiliate of LB or ordered by a court of competent jurisdiction to be paid or payable by LB or any Affiliate of LB, to the extent incurred as the result of (a) any breach of the warranties set forth in Section 3.6 above or (b) any claims (collectively, “LB Claims”) alleging LB’s use of the Cell Line, other ImClone Materials, the ImClone Information, ImClone Patent Rights or the 5000 Liter Process (other than steps or components which are or become part of the 5000 Liter Process by virtue of contributions of LB) in the course of the Services, infringes or is alleged to infringe any rights (including without limitation any intellectual property rights) of a third party (whether or not ImClone knows or ought to have known of such infringement or alleged infringement). Any lost Batch Price shall be included in the losses and damages resulting from any such breach or claim.

It is hereby agreed that LB shall notify ImClone as soon as is reasonably practicable of any claim, action or proceedings and shall at ImClone’s cost provide ImClone with reasonable assistance and relevant information to support ImClone to avoid, compromise or defend any such claim or action or proceedings. Further, unless the same conflict with or prejudice LB’s proper business interests or might reasonably be expected to do so LB shall at ImClone’s cost take such action as ImClone may reasonably and properly require to avoid, compromise or defend any such claim or action or proceedings. Nothing contained in this Section 3.7 shall oblige LB to take any action or steps in its own name in defending any claim, action or proceedings. The provisions of this Section 3.7 shall be LB’s sole and exclusive remedy in connection with the matters described in clauses (a) and (b) above.

3.8. Survival . The obligations of ImClone under Section 3.7 shall survive the end of the term or earlier termination of this Agreement.

4. Agreement to Supply .

4.1. cGMP Manufacture . LB will, in accordance with the terms of this Agreement, manufacture and Deliver (in accordance with Section 7.1) Batches of Product at 5000 liter scale in accordance with cGMP using the 5000 Liter Process and the 5000 Liter Manufacturing Suite. ImClone understands that as further defined in Section 4.3 additional product-specific development documentation and validation work may be required to support regulatory applications.

4.1.1 ImClone acknowledges and agrees to order the Minimum Order as defined herein, provided that LB passes all relevant regulatory authority and cGMP Inspections of LB’s facility to manufacture 5000L batches of Product.

4.1.2 LB shall make commercially reasonable efforts to manufacture the Minimum Order within approximately five (5) years from the Effective date of the Agreement. A campaign shall consist of a minimum series of three (3) batches of a single product. A minimum of * in the first year of the Agreement and a minimum of * to commence in each subsequent year. The number of campaigns and the number of batches in each campaign shall be agreed between Parties prior to the commencement of that calendar year.

4.2. LB Supply Obligations . For each Batch of Product ordered by ImClone hereunder, LB will perform all Services necessary to manufacture and Deliver the Product in accordance with cGMP, including:

4.2.1. Recover ampoules of the cell bank for the Cell Line and expand cultures to complete airlift fermentation at 5000 liter scale in the 5000 Liter Manufacturing Suite. Each Batch shall be produced as one lot from one ampoule of the cell bank provided by ImClone.

4.2.2. Clarify culture supernatant and purify using the 5000-Liter Process

4.2.3. Test the Product against the Specifications. Additional Product and in process samples may be taken at ImClone’s request for further analysis. Alternatively, additional tests may be performed by LB at a price and under terms and conditions to be agreed .

4.2.4. Review requirements (if any) for 5000 Liter Process modifications in order to meet the Specifications for manufacture of subsequent Batches

and notify ImClone of such proposed modifications. Any such 5000 Liter Process modifications are subject to Section 9.1.

4.2.5. Undertake cGMP review of lot documentation, define Product disposition, and issue a Certificate of Analysis.

4.2.6. Deliver the Product to ImClone.

4.2.7. Upon the FDA’s request, and at LB’s expense, conduct an FDA inspection of 5000 Liter Manufacturing Suite seeking approval to manufacture the Product at LB’s facility.

4.2.8. Upon ImClone’s request, LB shall permit an ImClone employee or representative to be present at LB’s facilities during the production of any Product by LB for ImClone or any inspection relating to such Product.

5. Order Quantities and Order Procedures .

5.1 Minimum Orders

The Minimum Order of ***** batches shall be scheduled by LB according to the freely available capacity in the 5000L suite as mutually agreed by ImClone. The first campaign shall be scheduled to commence within 4 months of initiation of the tech transfer of the first Product. Initiation of the tech transfer for the first Product is expected to commence within 4 months of the Effective Date of this Agreement.

5.2 Additional Orders .

Any orders required by ImClone in addition to the Minimum Order, shall be requested in writing to LB on a (12) month rolling basis, from the Effective Date of the Agreement. Any such

Additional orders shall be subject to LB’s freely available capacity in the 5000L suite as determined solely by LB.

5.3. Binding Order . Not later than six (6) months prior to Out of Freeze of any campaign, ImClone shall confirm the actual number of Batches it requires for manufacture. Upon LB’s acceptance of that confirmed number of batches a “Binding Order” shall arise for that number of Batches.

6. Provision of the Services .

6.1. Diligence . LB shall diligently carry out the Services in a professional and workman-like manner, consistent with industry standards for the contract manufacturing of biologics.

6.2. This Section left intentionally blank.

6.3. Cancellations .

ImClone may cancel batches under the Minimum Order on written notice to LB subject to the following cancellation fees:

6.3.1 ***** of the Batch Price for all such Batches cancelled within 6 months of commencement date of the Batches.

6.3.2 ***** of the Batch Price for all such Batches cancelled between the period seven (7) to twelve (12) months of commencement date of the Batches.

6.3.3 ***** of the Batch Price for all such Batches cancelled at greater than 12 months prior to the commencement date of the Batches.

6.3.4 For the avoidance of doubt ImClone may not cancel any Batch that has commenced manufacture

6.3.5 For the avoidance of doubt for any Binding Order or Contract Order in excess of the Minimum Order, ImClone may cancel any batch upon six (6) months prior written notice, without any financial penalty, provided that the batch commencement date for the canceled batch is at least six (6) months away.

6.3.6 Notwithstanding the foregoing, if ImClone cancels or reschedules a batch, LB will use good faith efforts to seek an alternative customer or customers to purchase the capacity which is reserved for ImClone so as to mitigate ImClone’s obligations under the Agreement. If LB is able to sell such capacity, ImClone’s obligation to compensate LB pursuant to Section 6.3 shall be adjusted accordingly.

6.4 Except as provided in this Article 6 or Section 17.4, ImClone shall not be entitled to cancel any unfulfilled part of the Services or to refuse to accept the Services on grounds of late performance, late delivery or failure to produce the estimated quantities of Product for delivery. LB shall not, except as provided in this Article 6, be liable for any loss, damage, costs or expenses of any nature, whether direct or consequential, occasioned by:

6.4.1. Any delay in performance or delivery howsoever caused; or

6.4.2. Any failure to produce the estimated quantities or number of Batches of Product for delivery.

6.5. This Section left intentionally blank

6.6. This Section left intentionally blank

6.7. Target Batch Yield . ImClone and LB each acknowledge that, due to the unpredictable nature of biological processes, 5000 Liter Process Product yield cannot be

guaranteed and may vary. The target per Batch yield of the modified 5000 Liter Process for the Product will be established by agreement of the parties (the “Modified Target Batch Yield”). If any Batch of Product (the “Actual Batch Yield”) is less than ninety percent (90%) of the Current Target Batch Yield or the Modified Target Batch Yield, as the case may be, (each a “Yield Deficiency”), ImClone and LB agree to adjust the Batch Price, on a pro-rata basis, to reflect such Yield Deficiency. If a Yield Deficiency exists ImClone shall be entitled to a cash payment (credited against the Price of that Batch) in an amount equal to (a) the Batch Price multiplied by *****. With regards to Products other than ERBITUX®, the parties agree that the target batch yield at the 5000 Liter Process will be at least 75% of the average yield ImClone generated from all cGMP batches at its 1000 liter facility scaled up to 5000 liters.

6.8. Supply Failure . If a situation of Force Majeure exists such that LB is unable (or the parties agree that there is no reasonable likelihood that LB will be able) to deliver to ImClone the Minimum Order and such further Binding Orders as may arise such event shall constitute a “Supply Failure.”

6.8.1. In addition to ImClone’s remedy under Section 6.10, Supply Failure shall entitle ImClone to exercise the right to elect within a sixty (60) day period to terminate this Agreement pursuant to Article 17.4.

6.8.2. In the event ImClone elects not to terminate but rather to treat the Supply Failure as a Late Delivery, the provisions of Section 6.10 shall apply

6.9. Compliance with Regulatory Requirements . LB shall comply, at LB’s cost, with all regulatory requirements from time to time applicable to the Services and in accordance with the other applicable legal and regulatory requirements of the federal, state and local jurisdictions

in which the 5000 Liter Manufacturing Suite is located. If ImClone requests LB to comply with any other legal or regulatory requirements, LB shall use reasonable commercial efforts to do so provided that:

6.9.1. ImClone shall be responsible for informing LB in writing of the precise requirements which ImClone is requesting LB to observe;

6.9.2. Such requirements do not conflict with any mandatory requirements under the laws of the location of the manufacture of the Product;

6.9.3. LB shall be under no obligation to ensure that the information furnished by ImClone pursuant to Section 6.9.1 complies with the applicable requirements of any jurisdiction; and

6.9.4. All costs and expenses properly incurred by LB in complying with ImClone’s requests regarding the requirements referred to in Sections 6.9.1 through 6.9.3 shall be charged to ImClone, in addition to the Price.

6.10. Late Delivery .

6.10.1. Where a Batch has been ordered by ImClone pursuant to Section 5.2 and is subject to an agreed date for delivery and LB fails to deliver said Batch by a date which is six (6) weeks after such date for delivery (subject to an extension of time for such delivery which LB may become entitled to hereunder) principally due to LB’s own fault, omission or unilateral scheduling change, ImClone shall be entitled to claim compensation for such late delivery. The compensation to which ImClone shall become entitled shall be equivalent to five percent (5%) of the Price of the Batch in question multiplied by the number of weeks (or fractions of weeks),

between the date six (6) weeks after the date for the Batch in question and the next date upon which a Batch is notified to ImClone as being ready for delivery.

6.10.2. Limitation on Liability. In no event shall compensation pursuant to this Section 6.10 on any one Batch exceed thirty five percent (35%) of the Price of the Batch in question, irrespective of whether such damages accrue as a result of any single event or a series of events or as a consequence of delay to delivery of a previous Batch. Such liquidated damages are a reasonable estimate of actual damages and do not represent a penalty. Notwithstanding the foregoing, where late delivery compensation has accrued on a parti

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