MANUFACTURING SUPPLY AGREEMENT

1.

As used in this Agreement, the following definitions shall apply:

1.1

“Act” shall mean the U.S. Food, Drug and Cosmetic Act of 1934, the Public Health Service Act of 1944 and the regulations promulgated thereunder, as the same may be amended from time to time.

1.2

“Active Pharmaceutical Ingredient” or “API” shall mean the active pharmaceutical ingredient of the Product.

1.3

“Affiliate” shall mean any corporation or non-corporate business entity, which directly or indirectly controls, is controlled by, or is under common control with a Party. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns or directly or indirectly controls at least fifty percent (50%) of the voting stock of the other corporation or (a) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate entity, the power to direct or cause the direction of the management and policies of such corporation or non-corporate entity, as applicable.

1.4

“Batch” or “Lot” shall mean, with respect to Product, each separate and distinct quantity of Product processed under continuous conditions and designated by a batch or lot number.

1.5

“cGMP Regulations” means Current Good Manufacturing Practices and pertinent guidelines that may be published by the FDA as defined from time to time under the Act, as codified in 21 CFR Parts 210 and 211 and being currently utilized within the pharmaceutical industry to manufacture the applicable type of Product(s) and equivalent regulations and guidelines in Europe.

1.6

“Certificate of Analysis” or “COA” shall mean a document certifying a Batch or Lot of Product meets all established and mutually agreed upon Specifications as referenced, signed and dated by a duly authorized representative of the Quality Control or Quality Assurance Department of JMPS or Client as the case may be.

1.7

“Confidential Information” shall mean any nonpublic information of JMPS or Client that will be communicated to the other Party including without limitation, trade secrets, business methods, operating procedures, manufacturing methods and processes, prices, and customer information, whether of a written, oral, visual or electronic nature, including but not limited to any such nonpublic information that may have been disclosed between the JMPS and Client from the date of that certain Confidential Disclosure Agreement dated August 14, 2002, as amended through and including the term of this Agreement.

1.8

“FDA” shall mean the United States Food and Drug Administration.

1.9

“Intellectual Property” shall mean property that can be protected under federal law, including patentable and copyrightable works, ideas, discoveries, and inventions.

1.10

“Product” shall mean JMPS Product No. 30017 - GCS-100LE Bulk Drug Substance, or such other Product specified in a Project Charter.

1.11

“Project Charter” shall mean a written document or documents numbered and signed by the Parties, describing the tasks, the activities, objectives, pricing and any additional terms and conditions required to manufacture the Product. Each Project Charter will be numbered and attached as an appendix in Exhibit A to this Agreement.

1.12

“Quality Agreement” shall mean a written document, mutually agreed to by the Parties, describing the obligations of the Parties with regards to compliance, quality systems, and testing and release of the Product. The Quality Agreement will be attached as Exhibit B to this Agreement.

1.13

“Regulatory Authority” shall mean any federal, state, local, or international regulatory agency, department, bureau, or other governmental agency having jurisdiction over the manufacture, sale, or distribution of Product, as agreed upon in a Project Charter, and “Regulatory Authorities” shall mean collectively all such regulatory authorities.

1.14

“Specially Regulated Waste” shall mean any Product refuse, remainder, residue, waste water or other discard material, including solid, liquid, semisolid, or contained gaseous material that arises from the manufacture of the Product(s) which may be subject to or require special handling, treatment, storage, or disposal under any federal, state or local laws or regulations.

1.15

“Specifications” shall mean (1) the performance parameters for which Product, ingredients and packaging components must comply to be considered acceptable and (2) the written record of such Product performance parameters annexed hereto within the applicable Project Charter attachment. Specifications may be amended from time to time by written agreement of the Parties.

1.16

“Client’s Technology Package” shall mean such technical information to be supplied by Client to JMPS to enable JMPS to carry out its obligations hereunder. Items which may be included in the Technology Package include, but is not limited to, Client’s raw material and manufacturing component specifications, intermediate and product specifications, analytical and microbiological method validation reports, analytical method transfer protocols, filter validation reports, raw material, intermediate and product storage specifications.

1.17

“Third Party” shall mean any party other than Client or JMPS and their respective affiliates.

2.

The Parties agree to the following provisions regarding Manufacturing Supply:

2.1

Client and JMPS shall jointly prepare and agree to in writing a Project Charter document, which may be amended from time to time as defined herein, for the Product, which shall, at a minimum, incorporate the following:

2.1.1

the Product manufacturing schedule;

2.1.2

the stages in which the Project Charter is to be executed (if any) and whether the commencement of each stage is dependent on successful completion of the previous stage;

2.1.3

identify the facilities, staffing, supplies, and equipment required for the Project Charter and who (Client or JMPS) is responsible for providing each of such items;

2.1.4

identify which Party is responsible for performing the various tasks or stages of the Project Charter;

2.1.5

Specifications as defined in Section 1.15;

2.1.6

a set of objective criteria whereby it can be assessed whether the Project Charter (and any stages thereof) has achieved its objectives;

2.1.7

identify all documents (Client’s Technology Package) and the timeline for delivery of such documents by Client to JMPS.

2.1.8

identify all documents (including regulatory documents) and other deliverables to be provided by JMPS to Client; and

2.1.9

a good faith estimate of the number of Batches or Lots required to complete the Project Charter.

2.1.10

define Project Charter prices; and

2.1.11

define Project Charter payment schedule in accordance with applicable milestones.

2.2

JMPS shall respond in a timely manner to Client’s inquiries regarding the status of any Project Charter.

2.3

JMPS and Client may from time to time negotiate in good faith changes to any Project Charter:

2.3.1

If such changes require JMPS to perform additional work or repeat work outside the original scope of the project, and such additional work is not required due to JMPS negligence, JMPS and Client shall negotiate in good faith the price and timing for such additional work.

2.4

Each Party shall provide the other Party, in a timely fashion, with all relevant information, documentation, and data necessary and appropriate for the Parties’ performance hereunder. Except as explicitly otherwise provided in this Agreement, in the event a Party is to review or approve any information, documentation, data, or other materials supplied by the other Party, such review or approval shall be completed within five (5) business days, unless additional time is requested based on a reasonable explanation provided within five (5) business days of the initial request.

2.5

Each Party shall use its commercially reasonable best efforts to successfully complete the Project Charter. However, the Parties agree and understand that neither Party hereto guarantees that the project will be successful or conducted in accordance with the project timetable nor warrants nor guarantees that a marketable product will result from the project.

2.6

JMPS shall have the right to review those portions of Client’s proposed regulatory submissions relating to JMPS facilities or procedures before the submissions are filed with Regulatory Authorities. JMPS shall complete its review of such submissions within ten (10) business days after receipt. JMPS shall consult with and advise Client in responding to questions from Regulatory Authorities regarding regulatory submissions for the Product.

2.7

Right of Negotiation to Manufacture: Subject to rights that may be granted by Client to third parties in connection with collaborative development and marketing arrangements, prior to commencing negotiations with any third party regarding the commercial manufacture of the Product, Client shall commence good faith negotiations regarding the same with JMPS. Client shall be under no obligation to enter into an agreement with JMPS for such commercial manufacture.

3.

The Parties agree to the following provisions regarding Intellectual Property Rights:

3.1

Ownership: The Parties agree that: (a) Client shall retain all of its ownership rights in and to Client’s Intellectual Property, (b) JMPS shall retain all of its ownership rights in and to JMPS Intellectual Property; (c) Client shall own all inventions made or conceived solely by Client; (d) JMPS shall own any inventions made or conceived solely by JMPS without using the Confidential Information of GlycoGenesys, and (e) Client shall own any inventions made or conceived jointly by the Parties in connection with the performance of this Agreement or by JMPS using the Confidential Information of GlycoGenesys.

3.2

License Grants: Client hereby grants to JMPS a nonexclusive, worldwide, royalty-free license during the term of this Agreement to use such Client Intellectual Property rights as are necessary for JMPS to perform JMPS obligations under this Agreement. JMPS hereby grants to Client a nonexclusive, worldwide, royalty-free, perpetual license to practice any rights JMPS has in any inventions made or conceived solely by JMPS in connection with the performance of this Agreement and incorporated into the manufacturing or packaging processes associated with the Product. JMPS shall not knowingly use any Third-Party intellectual property rights in the manufacturing processes developed by JMPS pursuant to a Project Charter. JMPS makes no other representation or warranty regarding Intellectual Property licensed hereunder.

3.3

Limitation on Use: Except as expressly stated in this Agreement, no Intellectual Property rights of any kind or nature are conveyed by this Agreement and neither Party shall have any right, title or interest in or to the other Party’s Intellectual Property rights for any purpose whatsoever without such other Party’s prior written consent. Upon termination of this Agreement for whatever reason, neither Party shall use or exploit in any manner whatsoever any Intellectual Property rights or nature belonging solely to the other Party.

4.

The Parties agree to the following provisions regarding equipment price:

4.1

Client shall pay for the price of equipment specifically purchased for the processing of Product including the price for purchasing and installing the equipment, as well as any and all maintenance costs associated with such equipment subject to Client’s prior approval of such prices, which approval shall not be unreasonably withheld. Client shall provide and JMPS shall hold in its possession a pectin dispensing meter, an industrial grade mixer, a [*****], and a [*****] at its manufacturing site, which is owned by and utilized solely for the benefit of Client for the processing of the Product herein. Client shall have the right to make such UCC filings on such equipment as it deems reasonably appropriate.

4.2

Client shall own equipment paid for by Client pursuant to Section 4.1. Client shall have the right to file such UCC filings as necessary to establish ownership of such equipment. JMPS may purchase such equipment within 15 days following the termination of this Agreement at the fair market value of such equipment at that time as mutually agreed by the Parties.

4.3

Any price associated with the maintenance of equipment owned by Client, removal of equipment and to return the facility in serviceable condition shall be borne by Client.

5.

The Parties agree to the following representations and warranties:

5.1

Each of the Parties represent and warrant to the other as follows:

5.1.1

It has full power and authority to enter into this Agreement and consummate the transactions contemplated hereby and that the terms of this Agreement are not inconsistent with other contractual obligations, expressed or implied, by which it is bound.

5.1.2

It has such permits, licenses, and authorizations of government or regulatory authorities as are necessary to own its respective properties, conduct its business and consummate the transactions contemplated hereby, provided however, that Client shall be solely responsible for obtaining all permits, licenses, and authorizations for JMPS to process and ship Product(s), except for securing approval of JMPS facility as a registered FDA facility, which shall be the responsibility of JMPS.

5.1.3

It is not currently under investigation for disbarment action, debarred, suspended, or otherwise excluded by the FDA or other Regulatory Authority from conducting business.

5.1.4

All laboratory, scientific, technical and/or other data submitted by or on behalf of Client or JMPS, as the case may be, relating to Product(s) shall, to the best of their knowledge, be true and correct and shall not contain any material falsification, misrepresentation or known omission.

5.2

JMPS represents and warrants to Client as follows:

5.2.1

Product(s) shall be processed in compliance with the Quality Agreement and all applicable laws.

5.2.2

Product(s), as processed and delivered, shall comply with Specifications and shall not be adulterated or misbranded within the meaning of the Act or other substantially similar laws and statutes, provided however that the foregoing shall not apply to the extent that any such breach is caused by any materials provided by Client or due to compliance with any Specifications or instructions provided by Client.

5.2.3

The manufacturing facilities for Product(s) shall conform, and will throughout the term of this Agreement, in all respects to applicable laws, regulations, and approvals governing such facility, including, but not limited to, the applicable cGMP Regulations and will be adequate to produce the quantities of Product(s) as detailed in the Project Charter(s). JMPS shall implement such requirements as may be necessary to comply with The Control of Substance Hazardous to Health (COSHH) Regulations of 1988, consolidated in 1994, amended in 1996, 1997 and 1998 and further consolidated in 1999 in connection with the performance of its obligations under this Agreement.

5.2.4

Neither it nor any person employed by it or to be employed by it to perform the Project Charter(s) (i) is presently under any obligation which conflicts with their duties contemplated hereunder and agrees not to undertake any project which will conflict with these duties during the conduct of the Project Charter(s), (ii) is under investigation by the FDA for debarment action or is presently debarred pursuant to the Generic Drug Enforcement Act of 1992, or (iii) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. Section 312.70 or the European Union equivalent. In the event any of the foregoing occurs, JMPS shall immediately notify Client.

5.3

Client represents and warrants to JMPS as follows:

5.3.1

Client has the full power and authority to grant the license it grants under this Agreement and neither the granting of such license nor the exercise by JMPS of the rights granted by Client under such license breaches any obligation to or right of any Third Party.

5.3.2

To Client’s knowledge, neither the Client’s Product technology, nor the use thereof by JMPS, shall infringe, violate nor misappropriate any patent, copyright, trademark, trade secret or other intellectual property of any Third Party.

5.3.3

Any excipients, API’s or other materials provided by Client to JMPS shall comply with Specifications and shall not be adulterated or misbranded within the meaning of the Act or other substantially similar laws and statutes.

5.3.4

Client will disclose to JMPS any information currently known or learned subsequent to the execution of this Agreement regarding toxicity, or other known health or environmental hazards or other safe handling requirements for the API or Product(s) as the case may be.

5.4

THE WARRANTIES SET FORTH HEREIN ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY EITHER PARTY UNDER THIS AGREEMENT, AND NEITHER PARTY MAKES ANY OTHER WARRANTIES EXPRESS OR IMPLIED OR ARISING BY LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY ARISING FROM THE COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.

5.5

EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS AGREEMENT AND IN THE EVENT OF A BREACH OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES WILL EITHER PARTY BE LIABLE TO THE OTHER UNDER ANY CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHER LEGAL OR EQUITABLE THEORY, FOR COVER OF ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST PROFITS IN CONNECTION WITH THE SUBJECT MATTER OF THIS AGREEMENT INCLUDING WITHOUT LIMITATION THE PRODUCT(S) OR ANY SERVICES PROVIDED IN CONNECTION WITH THE PRODUCT(S) EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS AGREEMENT OR AS SET FORTH IN ARTICLE 6.