Document:

Manufacturing Supply Agreement

 Exhibit 10.1 
  
 CONFIDENTIAL TREATMENT REQUESTED [*****] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 
  
 MANUFACTURING SUPPLY AGREEMENT 
  
 This AGREEMENT is made and entered into this 10th day of March 2005 (the “Effective Date”) by and between Johnson Matthey
Pharmaceutical Materials, Inc. d/b/a Johnson Matthey Pharma Services having a principal place of business at 25 Patton Road, Devens, MA 01432, (“JMPS”) and GlycoGenesys, Inc., having a principal place of business at 31 St. James Avenue,
Boston, Massachusetts 02116 (“Client”). Both JMPS and Client are referred to herein individually as “Party” and collectively as the “Parties.” 
  
 WITNESSETH THAT: 
  
 WHEREAS, JMPS has expertise, personnel, infrastructure, and the facility for, and experience in manufacturing components for pharmaceutical products and is willing to
provide such services to client companies in the pharmaceutical area and; 
  
 WHEREAS, Client has a commercial interest in the manufacture of the Product as hereafter defined and requests the services of JMPS in the manufacturing of such Product pursuant to the Project Charter and JMPS desires to manufacture such
Product on behalf of Client pursuant to such Project Charter and in accordance with the terms and conditions contained herein; 
  
 NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties agree as follows: 
  
 ARTICLE 1 
 DEFINITIONS 
  

	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. 

 ARTICLE 2 
 MANUFACTURING SUPPLY 
  

	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. 

  
 ARTICLE 3

 INTELLECTUAL PROPERTY RIGHTS 
  

	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. 

  
 ARTICLE 4 
 EQUIPMENT PRICE

  

	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.

  
 ARTICLE 5 
 REPRESENTATIONS AND WARRANTIES 
  

	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. 

  
 ARTICLE 6 
 NONCONFORMING PRODUCT 
  

	6.	In the event of Client finding the Product(s) do not conform to the Specifications, Client shall have thirty (30) calendar days from the date of its receipt of the Product(s) to
notify JMPS, specifying the respects in which the Product(s) is/are not acceptable. In the event that JMPS shall dispute any such determination by Client, the Parties shall use their best efforts to resolve the dispute amicably. If the Parties are
unable to do so, the matter shall be referred to an independent laboratory or consultant, mutually agreed to by both Parties, whose decision shall be final and binding. The Party against whom the dispute is decided shall pay for any charges for such
laboratory or consultant. JMPS liability will be limited, at no charge to Client, to repair of the non-conforming Product such that it complies with Specifications and has been produced in compliance with cGMP Regulations, or if repair is not
feasible, replacement of non-conforming Product, or if replacement is not feasible, refund of price paid by Client for such non-conforming Product. 

 ARTICLE 7 
 PRICE – PAYMENT 
  

	7.	The Parties agree to the following price and payment provisions: 

  

	 	7.1	The price to be paid by Client for the Project Charter shall be defined in the Project Charter Documents as such may be amended to this Agreement from time to time.

  

	 	7.2	JMPS shall submit invoices to Client reflecting the work completed in accordance with the applicable milestones described in the applicable Project Charter documents. The invoices
shall be sent to the following address: 

  
 GlycoGenesys, Inc, 
 Attention: Accounts Payable 
 31 St. James Avenue 
 Boston, Massachusetts 02116 
  

	 	7.3	All payments due hereunder to JMPS shall be sent to the following address: 

  
 Johnson Matthey Pharma Services 
 25 Patton Road 
 Devens, MA 01434 
 Attention: Accounts Payable 
  

	 	  	Client shall make any and all payments in accordance with the Project Charter described in Exhibit A hereto. 

  

	 	7.4	All prices for Product shall be on the basis of Product being shipped F.O.B. Devens, Massachusetts to Client’s plant in Burlington, Massachusetts, under “Freight
Collect” terms. Shipment of Product(s) and shipping conditions shall be arranged by JMPS, and the price and liability of such shipment borne by JMPS. 

  
 ARTICLE 8 
 CONFIDENTIALITY 
  

	8.	In carrying out Project Charter(s) it is recognized by JMPS and Client that each may have to disclose to the other Confidential Information. Since both Parties desire that
Confidential Information is properly protected they hereby agree as follows: 

  

	 	8.1	Form of Disclosure: Confidential Information may be disclosed in oral, written or electronic form. 

  

	 	8.2	Obligations: The receiving Party agrees to hold Confidential Information in strict confidence and to use it only for the purposes under this Agreement. The receiving Party agrees
not to disclose the Confidential Information to any Third Party unless prior written authorization has been obtained from the disclosing Party. These obligations shall not apply to Confidential Information: 

  

	 	8.2.1	which, at the time of disclosure, is in the public domain. 

  

	 	8.2.2	which, after disclosure, becomes part of the public domain by publication or otherwise, except by breach of this Agreement by the receiving Party. 

  

	 	8.2.3	which the receiving Party can demonstrate by its written records was in the receiving Party’s possession at the time of the disclosure, and which was not acquired directly or
indirectly, from the disclosing Party. 

	 	8.2.4	which is lawfully disclosed to the receiving Party on a non-confidential basis by a Third Party who is not obligated to the disclosing Party or any other Third Party to retain such
information in confidence. 

  

	 	8.2.5	which results from research and development by the receiving Party independent of such disclosure as shown by competent evidence. 

  

	 	8.2.6	which is required to be disclosed by legal process, but only that portion of Confidential Information which is legally required to be disclosed; provided, in each case the Party so
required to disclose such Confidential Information informs the other Party as promptly as practicable in order to enable the other Party to seek a protective order or other appropriate remedy. The Party required to disclose such Confidential
Information shall use its best efforts to limit the disclosure and maintain confidentiality to the extent possible. The Party required to disclose such Confidential Information shall give the other Party written notice of any Confidential
Information disclosed pursuant to this Section 8.2.6. 

  

	 	8.3	Both Parties covenant and agree that they have and shall maintain an appropriate internal program limiting the internal distribution of Confidential Information to those of its
Affiliates, subsidiaries, officers, or agents who require said Confidential Information so that either Party may use Confidential Information for the purpose set forth in this Agreement. The Parties may disclose each other’s Confidential
Information to third-party consultants but only to the extent that they require access to Confidential Information in order to enable each other to carry out the purpose of this Agreement. The Parties covenant and agree that before making any
Confidential Information available to said Affiliates, subsidiaries, officers, agents, or third-party consultants, they shall inform such parties of the confidential nature of such information and obtain their agreement to be bound by obligations of
confidentiality and non-use which are equivalent to or greater than those set forth in this Agreement. The receiving Party agrees to promptly notify the disclosing Party in writing if it becomes aware of a breach of this Article 8 by it or any party
to whom it disclosed Confidential Information pursuant to this Section 8.3. 

  

	 	8.4	The receiving Party hereby acknowledges that disclosure or use of Confidential Information may result in irreparable harm to the disclosing Party. Accordingly, the receiving Party
agrees that the disclosing Party shall have the right to seek equitable relief, including without limitation an injunction or temporary restraining order, in the event of any actual or threatened breach of this Article 8. 

 

	 	8.5	Upon the written request of the disclosing Party, Confidential Information in tangible or electronic form received by the receiving Party from the disclosing Party shall, at the
disclosing Party’s sole option and expenses either be destroyed or immediately returned and the receiving Party shall provide written certification that all copies of Confidential Information have been destroyed or returned; provided, however
the receiving Party may maintain a single copy of the Confidential Information and its work product containing Confidential Information solely for the purposes of monitoring or demonstrating its compliance with this Agreement or applicable laws or
regulations. 

  

	 	8.6	The obligations and duties of nondisclosure under Article 8 shall survive the termination or expiration of this Agreement for a period of seven (7) years thereafter.

  
 ARTICLE 9 
 INDEMNIFICATION 
  

	9.	The Parties agree to the following Indemnification clauses: 

  

	 	9.1	Indemnification by Client: Client shall indemnify, defend and hold JMPS, its Affiliates and their respective directors, officers, employees and agents harmless from and against any
damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) resulting from any Third Party claims or suits arising solely out of (1) the use, handling, distribution,
marketing or sale of the Product(s) except to the extent caused by JMPS negligent acts or omissions or willful misconduct in its performance of the Project Charter(s) or the manufacture or bulk packaging of the Product(s) or (2) Client’s
grossly negligent acts or omissions or willful misconduct. 

	 	9.2	Indemnification by JMPS: JMPS shall indemnify, defend and hold Client, its Affiliates and their respective directors, officers, employees and agents harmless from and against any
damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) resulting from any Third Party claims or suits arising solely out of (1) JMPS grossly negligent acts or
omissions or willful misconduct in its i) performance of the Project Charter(s) or ii) the manufacture or bulk packaging of the intermediate(s) and Product(s) which cause the Product to fail to meet agreed upon Specifications.

  

	 	9.3	Indemnification Procedures: 

  

	 	9.3.1	Any Party hereto seeking indemnification hereunder (in this context the “Indemnified Party”) shall notify the other Party (in this context the “Indemnifying
Party”) in writing reasonably promptly after the assertion against the Indemnified Party any claim or suit by a Third Party (a “Third Party Claim”) in respect of which the Indemnified Party intends to base a claim for indemnification
hereunder; provided, however, the failure to timely give such notice shall limit the Indemnifying Party’s liability for indemnification only to the extent the Indemnifying Party’s defense of such matter has been prejudiced.

  

	 	9.3.2	(1) The Indemnifying Party shall have the right, upon written notice given to the Indemnified Party within thirty (30) calendar days after receipt of the notice from the Indemnified
Party of any Third Party Claim, to assume the defense and handling of such Third Party Claim, at the Indemnifying Party’s sole expense, in which case the provisions of Section 9.3.2 (2) below shall govern. 

  
 (2) The Indemnifying Party shall select counsel reasonably acceptable to
the Indemnified Party in connection with conducting the defense and handling of such Third Party Claim, and the Indemnifying Party shall defend or handle the same in consultation with the Indemnified Party, and shall keep the Indemnified Party
appraised of the status of the Third Party Claim. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, which consent will not be unreasonably withheld, agree to a settlement of any Third Party Claim that
could directly or indirectly lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder. The Indemnified Party shall cooperate with
the Indemnifying Party and shall be entitled to participate in the defense or handling of such Third Party Claim with its own counsel at its own expense. 
  

	 	9.3.3	(1) If the Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) calendar days after receipt of the notice from the Indemnified Party of any
Third Party Claim, of the Indemnifying Party’s election to assume the defense or handling of such Third Party Claim, the provisions of Section 9.3.3 (2) below shall govern. 

  
 (2) The Indemnified Party may, at the Indemnifying Party’s expense,
select counsel in connection with conducting the defense or handling of such Third Party Claim and defend or handle such Third Party Claim in such manner as it may deem appropriate, provided, however, that the Indemnified Party shall keep the
Indemnifying Party timely appraised of the status of such Third Party Claim and shall not settle such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. If the Indemnified
Party defends or handles such Third Party Claim, the Indemnifying Party shall cooperate with the Indemnified Party and shall be entitled to participate in the defense or handling of such Third Party Claim with its own counsel and at its own expense.

  

	 	9.3.4	Except with regard to fraud or pursuant to Section 8.4 or Article 6, the indemnification remedies in this Article 9, enforced in accordance with Section 9.3, shall constitute the
sole and exclusive remedies of the Parties with respect to any matters arising under or relating to this Agreement. 

  

	 	9.4	Survival of Indemnification Obligations: The provisions of this Article 9 shall survive the expiration or termination of this Agreement for a period of five (5) years.

	 	9.5	Limitation of Liability and Claims: Neither Party shall be liable to the other Party for indirect, special, punitive, or consequential damages of any kind, including without
limitation lost profits or loss of good will or otherwise. JMPS’s liability to Client under this Agreement shall not exceed twice the costs paid by Client under the Project Charter. Client’s liability to JMPS shall not exceed $2,000,000.

  

	 	9.6	Insurance: Client shall obtain and maintain, either itself or through one or more of its affiliates, with reputable carriers, product liability insurance with limits of not less
than Five Million Dollars ($5,000,000) per claim/annual aggregate by no later than the scheduled manufacturing date for the first Batch of Product(s) delivered as part of the first Project Charter(s) conducted under this Agreement. JMPS shall
maintain commercial general liability insurance including premises and operations coverage of not less than $1,000,000 per occurrence and $2,000,000 per accident and will endeavor to provide property damages liability insurance of not less than
$1,000,000 per occurrence and $1,000,000 per accident. Upon request, each Party hereto shall have its insurance carrier(s) furnish the other Party hereto with a certificate that such insurance is in force. In the event of any non-renewal of such
coverage, the other Party hereto shall be given at least thirty (30) calendar day’s advance written notice thereof. 

  
 ARTICLE 10 
 TERM AND TERMINATION

  

	10.	The Parties agree to the following Term and Termination clauses: 

  

	 	10.1	Term: This Agreement shall remain in full force and effect for the longer of i) one (1) year from the Effective Date herein, or ii) until the expiration or termination of the
Project Charter, (the “Term”); provided that if a Party provides notice to the other of its desire to extend the term for an additional one year period no later than 75 days prior to the expiration of the then current Term and the Party
receiving such notice does not reject such extension in writing within 15 days of receipt, the term of this Agreement shall extend for an additional one year period. 

  

	 	10.2	Termination by Mutual Agreement: This Agreement may be terminated, at any time upon mutual written agreement between the Parties. 

  

	 	10.3	Termination for Default: This Agreement may be terminated by either Party in the event of material breach or default by the other Party of the terms and conditions hereof; provided,
however, the other Party shall first give to the defaulting Party written notice of the proposed termination or cancellation of this Agreement, specifying the grounds therefor. Upon receipt of such notice, with respect to such defaults as are
capable of being cured, the defaulting Party shall have forty-five (45) calendar days to respond by curing such default. If the breaching Party does not respond or fails to work diligently to cure such breach within the additional time set forth
above, then the other Party may either suspend the Agreement indefinitely or terminate the Agreement. Termination of this Agreement pursuant to this Section 10.3 shall not affect any other rights or remedies that may be available to the
nondefaulting Party. 

  

	 	10.4	Termination by Client: This Agreement may be terminated by Client upon 90 days prior written notice to JMPS. 

  

	 	10.5	Bankruptcy; Insolvency: 

  

	 	10.5.1	Either Party may terminate this Agreement upon the occurrence of any of the following with respect to the other Party: 

  

	 	10.5.1.1	The entry of a decree or order for the relief by a court having jurisdiction in the premises in respect of such other Party in an Involuntary case under the Federal Bankruptcy Code,
as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive calendar days;

	 	10.5.1.2	The filing of such other Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or by any other applicable federal or state
insolvency or other similar law, or; 

  

	 	10.5.1.3	The failure of such other Party to pay its debts when due. 

  

	 	10.5.2	JMPS shall notify Client of its intent to file for protection under the Federal Bankruptcy Code as soon as such a determination is made, in which case, JMPS will segregate all
Client-related documents, including, but not limited to, manufacturing and analytical equipment protocols, qualifications, procedures, methods, calibrations reports and/or certificates, Specifications, Manufacturing Procedures, Intermediate and
Product analytical data, JMPS facility documentation in support of Project Charters; all Client provided manufacturing and analytical testing equipment, including any equipment purchased by Client for JMPS in conjunction with the Project Charter;
all unconsumed raw materials provided by Client to JMPS in conjunction with the Project Charter; and all Product Batches, that were produced in accordance with the Project Charter. At such time, JMPS will provide Client complete and total access to
these materials at Client’s request. 

  

	 	10.6	Rights and Duties Upon Termination: 

  

	 	10.6.1	Upon termination of this Agreement, JMPS shall, promptly as practicable, cease work on the Project Charter and, unless Client shall be in an uncured default of payment (which shall
not include outstanding invoices for which payment is not yet due), turn over to Client one (1) copy of all results, documentation and information obtained during the Project Charter (whether in written or electronic form) and all Product Batches,
as well as all unconsumed raw materials provided by Client which are then in JMPS possession and which are the property of Client in accordance with this Agreement. Additionally, all equipment outlined in Section 4.1 shall be returned to Client.

  

	 	10.6.2	Upon termination of this Agreement, Client shall remain liable for all fees, expenses, and uncancellable obligations incurred hereunder through the date of such termination.

  
 ARTICLE 11 
 FORCE MAJEURE/DISPUTE RESOLUTION 
  

	11.	The Parties agree to the following Force Majeure/Dispute Resolution clauses: 

  

	 	11.1	Effect of Force Majeure: Neither Party shall be held liable or responsible for any loss or damages resulting from any failure or delay in its performance due hereunder (other than
payment of money) caused by force majeure. As used herein, force majeure shall be deemed to include any condition beyond the reasonable control of the affected Party including, without limitation, war, riot, earthquake, tornado, hurricane, flood or
other natural disasters, fire, civil disorder, explosion, accident, sabotage, lack of or inability to obtain adequate fuel, power, materials, labor, containers, transportation, supplies or equipment, compliance with governmental requests, laws,
rules, regulations, orders or actions; inability despite best efforts to renew operating permits or licenses from local, state or federal governmental authorities; breakage or failure of machinery or apparatus; national defense requirements; or
supplier strike, lockout or injunction. JMPS shall notify Client of any foreseeable force majeure events, including, but not limited to, shipping interruptions or problems, and inability to procure supplies necessary for JMPS to perform any of its
obligations under this Agreement. 

  

	 	11.2	Notice of Force Majeure: In the event either Party is delayed or rendered unable to perform due to force majeure, the affected Party shall give notice of the same and its expected
duration to the other Party promptly after the occurrence of the cause relied upon, and upon the giving of such notice the obligations of the Party giving the notice will be suspended during the continuance of the force majeure; provided, however,
such Party shall take commercially reasonable steps to remedy or mitigate the force majeure with all reasonable dispatch. 

	 	11.3	Dispute Resolution: The Parties hereto agree to perform the terms of this Agreement in good faith, and to attempt to resolve any controversy, dispute or claim arising hereunder in
good faith. Any dispute regarding the validity, construction, interpretation, or performance of this Agreement (other than provisions, hereof relating to any intellectual property rights, or the confidentiality obligations contained in Article 8
hereof) shall be (1) first attempted to be resolved between the CEO/President of each Party and failing that (2) submitted to binding arbitration in Boston, Massachusetts, U.S.A. to be conducted in accordance with the Arbitration Rules of the
American Arbitration Association (“AAA”); provided, however, that nothing in this Section 11.3 shall be construed to preclude either Party from seeking provisional remedies, including, but not limited to, temporary restraining orders and
preliminary injunctions, from any court of competent jurisdiction, in order to protect its rights pending arbitration, but such preliminary relief shall not be sought as a means of avoiding arbitration. Any arbitration hereunder shall be submitted
to an arbitration tribunal made up of three (3) members, one of whom shall be selected by Client, one of whom shall be selected by JMPS, and one of whom shall be selected by the other two arbitrators. The order or award of the arbitrators shall be
final and may be enforced in any court of competent jurisdiction. The prevailing Party in any legal or arbitration action brought by one Party against the other Party shall be entitled, in addition to any other rights and remedies it may have, to
reimbursement for its expenses incurred thereby, including court cost and reasonable attorney’s fees. The Parties shall have the right of limited prehearing discovery, including: 

  

	 	11.3.1	exchange of witness lists; 

  

	 	11.3.2	exchange of documentary evidence and reasonably related documents; 

  

	 	11.3.3	written interrogations; and 

  

	 	11.3.4	subject to reasonable discretion of the arbitrators and upon good cause shown depositions under oath of any witnesses who are to be called to testify at the arbitration hearing.

  

	 	11.4	As soon as the discovery is concluded, the arbitrators shall hold a hearing in accordance with the aforesaid AAA rules. 

  
 ARTICLE 12 
 NOTICES 
  

	12.	All notices provided herein shall be in writing and shall be deemed to be delivered when deposited in the United States mail, postage prepaid, or hand-delivered to an authorized
representative of the Party to whom notice is directed, or sent by facsimile, or express service courier, charges prepaid, to the address of the other Party designated below: 

  

			
	Client	 	JMPS
		
	GlycoGenesys, Inc.	 	Johnson Matthey Pharma Services
	31 St. James Avenue	 	25 Patton Road
	Boston, MA 02116	 	Devens, MA 01432
	Attention: Bradley Carver	 	Attention: Lee Piver
	FAX: (617) 422-0675	 	Fax: (978) 784-5500

  
 The addresses and
persons provided above may be changed by either Party by providing the other Party with written notice of such change. 

 ARTICLE 13 
 MISCELLANEOUS 
  

	13.	The Parties agree to the following miscellaneous clauses: 

  

	 	13.1	Entire Agreement: This Agreement, attachments and exhibits contain the entire understanding between the Parties with respect to the subject matter hereof, and may be modified, only
by a written instrument duly executed by each Party’s authorized representative, which shall be made a part of this Agreement. 

  

	 	13.2	Independent Contractor: Nothing herein shall create any equity association, partnership, joint venture, or ownership relation of principal and agent between the parties hereto, it
being understood that Client is purchasing JMPS services as an independent company, and neither Party shall have the authority to bind the other party or the other’s representatives in any way. 

  

	 	13.3	Publicity: Except as explicitly set forth below in Section 13.4, any press release, publicity or other form of public written disclosure related to this Agreement prepared by one
Party shall be submitted to the other party prior to release for written approval, which approval shall not be unreasonably withheld or delayed by such other Party. 

  

	 	13.4	Use of Party’s Name: Except as expressly provided or contemplated hereunder and except as otherwise required by applicable law, no right is granted pursuant to this Agreement
to either Party to use in any manner the trademarks or name of the other Party, or any other trade name, service mark, or trademark owned by or licensed to the other Party in connection with the performance of the Agreement. To the extent required
by applicable law, the Parties shall be permitted to use the other Party’s name and disclose the existence and terms of this Agreement in connection with required public regulatory filings, public securities filings and private placement
memoranda and documentation, using reasonable commercial efforts to protect the confidentiality of the terms of this Agreement. 

  

	 	13.5	Severability: Each Party hereby expressly agrees that it has no intention to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body of any country or community or association of countries; that if any word, sentence, paragraph, clause or combination thereof in this Agreement is found by a court or executive body with judicial powers having
jurisdiction other this Agreement or either Party hereto, in a final unappealed order, to be in violation of any such provisions in any country or community or association of countries, such words, sentences, paragraphs, clauses or combination shall
be inoperative in such country or community or association of countries and the remainder of this Agreement shall remain binding upon the Parties, so long as enforcement of the remainder does not violate the Parties’ overall intentions in this
transaction. 

  

	 	13.6	Assignment; Subcontractors: This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however,
either Party may, without such consent, assign this Agreement 

  

	 	13.6.1	in connection with the transfer or sale of all or substantially all of the assets or voting securities of such Party or the line of business of which this Agreement forms a part, or

  

	 	13.6.2	in the event of a merger or consolidation of a Party hereto with another company or to any Affiliate of the assigning Party fully capable of performing hereunder.

  
 Any purported assignment in violation of the
preceding shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve either Party of responsibility for the performance of any obligation that accrued prior to the effective
date of such assignment. 
  

	 	13.7	Governing Law: This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, irrespective of any conflicts of law rule which
may direct or refer such determination of applicable law to any other state; and if this Agreement were performed wholly within the Commonwealth of Massachusetts. 

	 	13.8	Headings: Paragraph headings and captions used herein are for convenience of reference only and shall not be used in the construction or interpretation of this Agreement.

  

	 	13.9	Continuing Obligations: Termination, assignment or expiration of this Agreement shall not relieve either Party from full performance of any obligations incurred prior thereto.

  

	 	13.10	Waiver: Waiver by either Party of any of its rights under this Agreement or applicable law must be in writing and signed by the waiving Party. Neither Party’s waiver of any
breach or failure to enforce any of the terms and conditions of this Agreement, at any time, shall not in any way affect, limit or waive such Party’s right thereafter to enforce and comJMPS strict compliance with every term and condition of
this Agreement. 

  

	 	13.11	Construction: This Agreement has been jointly prepared on the basis of the mutual understanding of the Parties and shall not be construed against either Party by reason of such
Party’s being the drafter hereof or thereof. 

  

	 	13.12	Exhibits, Schedules and Attachments: Any and all exhibits, schedules and attachments referred to herein form an integral part of this Agreement and are incorporated into this
Agreement by such reference. 

  

	 	13.13	Material, Waste and Specially Regulated Waste: Unless otherwise expressly agreed in a Project Charter, Client shall be charged for all material and waste charges, and for the costs
associated with the removal of Specially Regulated Waste, at cost plus 8%. Client will be notified of the determination of Specially Regulated Waste and advised of the price for destruction of said Specially Regulated Waste.

  
 IN WITNESS WHEREOF, this Agreement has been executed by the
Parties as of the day and year first written above. 
  

			
	 FOR: JOHNSON MATTHEY PHARMACEUTICAL
 MATERIALS,
D/B/A JOHNSON MATTHEY PHARMA
 SERVICES
	  	FOR: GLYCOGENESYS, INC.
		
	 /s/ S. A. Zahr

	  	 /s/ Bradley J Carver

	Signature	  	Signature
		
	 S. A. Zahr

	  	 Bradley J Carver

	Printed Name	  	Printed Name
		
	 General Manager and Vice President

	  	 President and CEO

	Title	  	Title
		
	 3/10/05

	  	 3/7/05

	Date Signed	  	Date SignedAseptic Fill Manufacturing Agreement

 Exhibit 10.2 
  
 CONFIDENTIAL TREATMENT REQUESTED [*****] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.
ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 
  
 ASEPTIC FILL MANUFACTURING AGREEMENT 
  
 This Aseptic Fill Manufacturing Agreement is made this 14th day of January, 2005 by and between GlycoGenesys, Inc. with its principal
offices located at 31 St. James Avenue, 8th Floor, Boston MA 02116 (hereinafter referred to as “CLIENT”)
and Hyaluron, Inc., a corporation, with its principal place of business located at 99 South Bedford Street, Burlington, MA 01803, (hereinafter referred to as “HYALURON”); 
  
 WHEREAS, CLIENT is the owner or licensee of patents, trade secrets, trademarks, formulations and know-how related to the pharmaceutical
product known as GCS-100LE (hereinafter referred to as the “Drug Product”); 
  
 WHEREAS, HYALURON has the expertise, personnel, quality systems and the manufacturing facility suitable for aseptic processing, formulation, filling, visual inspection, labeling, QC testing, storage, shipping, and bulk packaging of the Drug
Product; 
  
 WHEREAS, CLIENT wishes to have HYALURON perform some or all of the
above services with respect to the Drug Product as agreed and HYALURON wishes to provide the agreed services to CLIENT; 
  
 NOW THEREFORE, in consideration of the premises and the undertakings, terms, conditions and covenants set forth below, the parties hereto agree as follows: 
  

	 	I.	DEFINITIONS 

  

	 	a.	Bulk Drug Substance or Active Pharmaceutical Ingredient (API) shall mean the un-formulated Bulk Drug Substance or Active Pharmaceutical Ingredient used as starting material,
delivered by CLIENT (at its cost), to HYALURON for formulating and processing. 

  

	 	b.	Bulk Formulated Drug shall mean the formulated Bulk Drug Substance or formulated Active Pharmaceutical Ingredient, either formulated by HYALURON or delivered by CLIENT (at its
cost), to HYALURON for processing. 

  

	 	c.	Bulk Drug Product shall mean the Bulk Formulated Drug that has been sterile filtered but not yet filled. 

  

	 	d.	Drug Product shall mean the aseptically filled drug in final dosage form meeting Product Specifications. 

  

	 	e.	Product Specifications shall mean those products, labeling, and performance specification developed and/or filed with the FDA or other appropriate regulatory agencies as such set
forth in the Exhibit I, Product Specifications. 

  

	 	f.	Certificate of Analysis, or COA, of Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug or Bulk Drug Product or Drug Product shall mean documentation
certifying this material meets all of CLIENT’S required analytical and microbiological specifications. 

  

	 	g.	cGMP Regulations means Current Good Manufacturing Practices as defined from time to time under the Act, as codified in 21 CFR Parts 210 and 211 and associated guidelines and
equivalent European regulations and guidelines and being currently utilized within the pharmaceutical industry to manufacture the applicable type of Product(s) and shall include pertinent FDA guidelines for aseptically filled products.

  

	 	h.	Retain Samples shall mean any Drug Product samples retained throughout the manufacturing process as required by the CLIENT and/or applicable regulatory agencies.

  

	 	i.	Bulk Sterility Testing shall mean testing performed on Bulk Drug Product to ensure that it is free of any microbiological contamination to within USP specifications.

  

 1 

	 	j.	Final Sterility Testing shall mean testing performed on the Drug Product to ensure that it is free of any microbiological contamination as required by CLIENT and/or regulatory
agencies. 

  

	 	k.	Final Endotoxin Testing shall mean Bacterial Endotoxin Testing (BET) on the Drug Product to ensure that it does not exceed endotoxin limits as required by regulatory agencies.

  

	 	l.	IND shall mean an Investigational New Drug Application for the Drug Product, as defined in the United States Food and Drug Administration (FDA) rules and regulations, 21 CFR.

  

	 	m.	Batch or Lot shall mean, with respect to Product(s), each separate and distinct quantity of Product processed under continuous conditions and designated by a distinctive batch or
lot number 

  

	 	II.	PROJECT SCOPE 

  

	 	a.	HYALURON will, in accordance with all recent meetings, correspondence, and/or communications between it and CLIENT, including HYALURON’s proposal as accepted by CLIENT, be
responsible for aseptic processing and manufacture of CLIENT’S Drug Product according to cGMP Regulations. 

  

	 	b.	Upon Execution of this Agreement, HYALURON shall proceed with all such processing and manufacturing in full accordance with the fill date and other timings (Exhibit II) and
procedures as set forth in this contract. 

  

	 	c.	HYALURON will process each batch of Drug Product using components and ingredients listed in Exhibit III attached. 

  

	 	III.	HYALURON’S RESPONSIBILITIES 

  

	 	a.	Perform formulation of the Bulk Drug Substance or Active Pharmaceutical provided by CLIENT (if required by this contract). 

  

	 	b.	Perform sterile filtration of the Bulk Formulated Drug. 

  

	 	c.	Furnish all labor to prepare the components listed in Exhibit III and sterilizing these items according to validated procedures. 

  

	 	d.	Furnish all labor to conduct the appropriate raw material, in-process, and Drug Product testing as required in Exhibit IV attached. 

  

	 	e.	Furnish all necessary labor to aseptically fill vials within tolerance limits established by CLIENT in Exhibit III attached. 

  

	 	f.	Perform Final Sterility Testing and Final Endotoxin Testing on the Drug Product as a requirement prior to release. 

  

	 	g.	Provide necessary labor to perform 100% visual inspection of Drug Product. 

  

	 	h.	Provide necessary labor to label Drug Product. 

  

	 	i.	Provide necessary space to store Drug Product. 

  

	 	j.	Provide necessary labor to bulk pack each batch of Drug Product units into appropriate shipping containers to ensure proper storage temperature during normal transit to CLIENT.

  

	 	k.	Provide necessary labor to prepare shipment of Drug Product units to CLIENT or to CLIENT’S designated consignee. 

  

	 	l.	Ship all Drug Product to CLIENT or to CLIENT’S designated consignee in accordance with the delivery Schedule specified in Exhibit II. 

  

	 	m.	Provide equipment necessary to monitor the temperature of the Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug or Bulk Drug Product and/or the Drug
Product while in transit to assure that the product is maintained as required by CLIENT. 

  

	 	n.	A Certificate of Analysis for each batch delivered shall record the item tested, method, SOP/USP reference, specification and test result. 

  

	 	o.	Supply essential documents in support of the Chemistry, Manufacturing and Control section of CLIENT’S supplemental regulatory filing(s) in the U.S. or the equivalent in other
jurisdictions. 

  

 2 

	 	p.	Provide a drug master file cross reference letter when available. 

  

	 	q.	Shall request reasonably promptly the supply of reference standards as required. 

  

	 	r.	Shall store and maintain the reference standards according to instructions supplied by CLIENT and shall ensure the appropriate use of the reference standards.

  

	 	s.	Furnish all labor to produce a new GCS-100LE reference standard to replace the existing reference standards. 

  

	 	t.	Control the reference standard distribution after the new lot of reference standard is prepared. 

  

	 	IV.	CLIENT RESPONSIBILITIES 

  

	 	a.	Furnish HYALURON with Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug, at no cost to HYALURON, together with a Certificate of Analysis at least two
(2) weeks prior to the fill date. The Certificate of Analysis certifies that the Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug is free of endotoxin contaminants and meets all of CLIENT’S required analytical and
microbiological specifications. 

  

	 	b.	Provide HYALURON with a current MSDS for the Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug. 

  

	 	c.	Furnish HYALURON with complete Drug Product Specifications. 

  

	 	d.	Provide HYALURON with an initial supply of Product specific reference standards to conduct appropriate in-process and Drug Product testing as required in Exhibit IV and
qualification documents stating the expiry or retest date of such reference standards. 

  

	 	e.	Be responsible for the additional costs associated with utilization of an aseptic process that is new or different from the validated aseptic processing cycles HYALURON customarily
employs. 

  

	 	f.	Be responsible for any product specific testing including potency assays unless otherwise specified in the attached proposal noted in Exhibit IV attached.

  

	 	g.	Be responsible for product specific tests for final release of each batch of the Drug Product to confirm it meets Specifications. If required, HYALURON shall send a sample of each
batch of the Drug Product manufactured pursuant to this Agreement, at CLIENT’S cost, to a location designated by CLIENT as required in Exhibit IV for the purpose of test in accordance with the final Drug Product Specification, before delivery
of the batch to CLIENT or CLIENT’s designation consignee. 

  

	 	h.	As required by the FDA, CLIENT shall assume full responsibility for final release of each lot of the Drug Product for its intended use. 

  

	 	i.	Provide HYALURON with written specifications as to environmental conditions during shipping and name and address of the recipient and shipping date. 

  

	 	j.	Provide HYALURON with a validated rework procedure (if CLIENT has established such a rework procedure). 

  

	 	k.	Provide HYALURON with methods and specifications for in-process and final Drug Product testing as specified in Exhibit IV attached. 

  

	 	l.	Furnish HYALURON with equipment decontamination procedures including a residual product test method and residual product limit with acceptance criteria. 

  

	 	m.	Provide HYALURON with a copy of the CMC, or equivalent, section, prior to submission, of the relevant regulatory submissions for HYALURON review and comment (e.g., IND or NDA).

  

	 	V.	PRICING AND SCHEDULING 

  

	 	a.	The current price quotation for the production of Drug Product units is attached as Exhibit II. 

  

	 	b.	The cost of the project may be revised if current manufacturing responsibilities, procedures and/or analytical requirements are revised by CLIENT and agreed to in writing by
HYALURON. 

  

	 	c.	If proposed filling dates listed (Exhibit II) are estimates, HYALURON will make a “best effort” to accommodate CLIENT needs until such time CLIENT can provide
HYALURON with exact fill 

  

 3 

 dates. However, if these dates conflict with ongoing HYALURON business commitments, then HYALURON will
give CLIENT an opportunity to reserve alternate fill dates before scheduling fill dates to other clients. 
  

	 	d.	CLIENT shall complete and provide HYALURON in writing, at least two weeks in advance of a planned fill date, all information requested on Exhibit V attached. All information
in Exhibit V must be completed to prevent any delays. 

  

	 	VI.	PAYMENT 

  

	 	a.	An amount equal to 50% of the total contract price shall be made to HYALURON at the time of execution and delivery of the contract. The remainder will be invoiced to CLIENT as noted
below. 

  

	 	b.	Invoices are due within 30 days of receipt. The invoice date will be the date CLIENT’S Quality Assurance Department has released the lot. 

  

	 	c.	All invoices paid later than forty-five (45) days from date of invoice will be charged 1.5% simple interest per month. 

  

	 	VII.	CHANGE IN SCOPE 

  

	 	a.	Changes by CLIENT: 

  

	 	i.	CLIENT must approve, in writing, the Product Specification Sheet, Exhibit I, at least two weeks prior to the date of manufacture. If CLIENT requests a change to the Product
Specification Sheet and HYALURON agrees that such change is feasible with regard to the manufacture of the Drug Product, such change shall be incorporated within the specifications pursuant to a revision of the Product Specification Sheet (PSS).
This amended PSS must be approved by both parties, in writing, and attached to Exhibit VI, Contract Amendments. 

  

	 	ii.	The price of the Drug Product manufactured shall be adjusted for any such change in Section VII.a.i. above, and CLIENT shall pay HYALURON the costs associated with such change,
including any development work, if necessary, based upon HYALURON’s then-prevailing development rates. 

  

	 	iii.	Such prices and costs shall be set forth in written amendment to this Agreement. 

  

	 	iv.	It is the responsibility of CLIENT to ensure that proper regulatory agencies approve the suggested changes. 

  

	 	b.	Changes by HYALURON: 

  

	 	i.	HYALURON agrees that any changes developed by HYALURON that may be incorporated into the Drug Product shall be set forth in a revision of the PSS and agreed to by CLIENT in writing
prior to such incorporation. This amended PSS should be attached to Exhibit VI. 

  

	 	VIII.	STABILITY REQUIREMENTS 

  

	 	a.	CLIENT will maintain all samples necessary for stability testing for each batch of Drug Product unless this activity has been contracted to HYALURON as stated in the “Quality
Control Testing Performed at HYALURON” section of Exhibit IV and detailed in Exhibit VI both attached. 

  

	 	i.	If CLIENT requests, HYALURON can monitor and perform stability studies for CLIENT. 

  

	 	ii.	If requested, HYALURON will provide an estimate of the time required and the costs associated with performing and monitoring such stability studies. 

  

	 	b.	CLIENT is responsible for any additional testing which CLIENT may deem necessary but is not included in this Agreement. 

  

	 	c.	HYALURON reserves the right to maintain a minimum number of samples as specified in Exhibit IV, from each batch agreed to by CLIENT in the event of an Out of Specification
test results. 

  

 4 

	 	IX.	CANCELLATION 

  

	 	a.	Cancellation of scheduled reserved production dates, other than by reason of CLIENT’s termination of the Agreement because of HYALURON’s breach, default, insolvency or
bankruptcy, will incur the following cancellation fees in addition to the amount stipulated and paid as set forth in Section VI, Paragraph A: 

  

	 	b.	All cancellation and rescheduling requests must be submitted in writing. 

  

	 	c.	Cancellation or rescheduling of clinical runs will incur the following fees: 

  

					
	 Number of days before scheduled run

	  	 Rescheduling Fee
 (if rescheduled within 60 days
 of initial fill date)

	    	 Cancellation Fee

	16 – 30 days	  	0% of Manufacturing Task Price	    	50% of Manufacturing Task Price
			
	8 – 15 days	  	75% of Manufacturing Task Price	    	75% of Manufacturing Task Price
			
	0-7 days	  	100% of Manufacturing Task Price	    	100% of Manufacturing Task Price

  
 When canceling an
entire project, the client forfeits the initial deposit paid at the beginning of the project and is responsible for project costs incurred up to the date of receipt of the cancellation notice as well as any associated costs to close down the
project. 
  

	 	X.	LIABILITY 

  

	 	a.	Acts of God 

  

	 	i.	HYALURON shall not be liable for damages for, nor shall this agreement be terminable by reason of, any delay or default in HYALURON’s performance hereunder if such a delay or
default is caused by conditions beyond HYALURON’s control including, but not limited to, acts of God, regulation or law or other action of government or any agency thereof, war, insurrection, civil commotion, destruction of production
facilities or materials by earthquakes, fire, flood or storm, labor disturbances, epidemic, or failure of suppliers, public utilities or common carriers. Performance shall be excused only to the extent of and during the reasonable continuance of
such event. HYALURON agrees to promptly notify CLIENT of any interruptions of supply as described above and to employ all reasonable efforts toward prompt resumption of its performance when possible if such performance is delayed or interrupted by
reason of such event. 

  

	 	b.	Failure to Supply 

  
 If CLIENT fails to supply HYALURON with Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug in time for processing, the
scheduled run will be cancelled and will incur cancellation fees as set forth in Section IX unless the failure to supply is due to factors including, but not limited to, acts of God, regulation or law or other action of government or any agency
thereof, was, insurrection, civil commotion destruction of production facilities or materials by earthquakes, fire, flood or storm, labor disturbances, epidemic, or failure of suppliers, public utilities or common carriers. Furthermore, HYALURON
cannot guarantee to meet previously agreed upon time lines with regard to Drug Product shipment related to such Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated Drug. Once all applicable cancellation fees, as set forth in
Section IX are fully paid, the manufacturing run will be rescheduled and HYALURON will require a prepayment fee of not less than 50% of the contracted price of the project being rescheduled. 
  

 5 

	 	c.	Replacement of Drug Product 

  

	 	i.	If, due to any negligent act or omission or failure to comply with the provisions of this Agreement on HYALURON’s part in the examination of Bulk Drug Substance or Active
Pharmaceutical Ingredient or Bulk Formulated Drug supplied by CLIENT, the Drug Product manufactured hereunder fails to conform with the Drug Product Specifications, HYALURON’s sole liability in such case shall be limited to replacement of Drug
Product (equal to but not more than the contract filling cost of the batch with the exclusion of any previously incurred cancellation fees), at no additional cost to CLIENT. 

  

	 	ii.	Notwithstanding the foregoing to the contrary, this Section X, Paragraph C, shall not limit any liability of HYALURON under Section XVI. 

  

	 	d.	Microbiological Failure: 

  

	 	i.	If the clinical batches produced by HYALURON do not meet the microbiological acceptance criteria as described in CLIENT’S release specifications, HYALURON will launch a failure
investigation and provide CLIENT with a copy of the final investigation report within 45 days of such failure. In addition, the CLIENT will retest reserve samples of Bulk Drug Substance or Active Pharmaceutical Ingredient to confirm it met the
original microbiological acceptance criteria prior to shipment to HYALURON. 

  

	 	ii.	If, after the failure investigation and retesting, the Drug Product failure is due to HYALURON’s negligence, or failure to comply with the provisions of this Agreement,
HYALURON will rework the Drug Product at no additional cost to CLIENT. If the Drug Product cannot be reworked, HYALURON will, notwithstanding the provisions of Section XVI, Paragraph B, maintain a limit of liability not more than the contract
filling cost of the batch only. 

  

	 	e.	Nonconforming Drug Product 

  

	 	i.	CLIENT shall have a period of thirty (30) days from the date of its receipt of a shipment of Drug Product to examine and reject such shipment for nonconformance with the Product
Specifications. 

  

	 	ii.	If CLIENT rejects such shipment, it shall promptly notify HYALURON and provide to HYALURON samples of such shipment for testing. 

  

	 	iii.	HYALURON reserves the right to test samples set aside under Section VIII, Paragraph C. 

  

	 	iv.	If HYALURON tests such shipment and determines that it did conform to the Drug Product Specifications, the parties shall submit samples of such shipment to a mutually acceptable
independent laboratory for testing. 

  

	 	v.	If such independent laboratory determines that the shipment conformed to the Drug Product Specifications, CLIENT shall bear all expenses of shipping and testing such shipment
samples. 

  

	 	vi.	If such independent laboratory confirms that such shipment does not meet the Drug Product Specifications, HYALURON shall bear all expenses of shipping and testing such shipment
samples. 

  

	 	vii.	The batch, found to be nonconforming because of HYALURON action or lack thereof, shall be disposed of as directed by CLIENT, at HYALURON’s expense. 

  

	 	viii.	Any Drug Product that CLIENT does not reject in the aforesaid thirty (30) day period pursuant to this Section X, shall be deemed accepted, and all claims with respect to the Drug
Product not conforming to Product Specification shall be deemed waived by CLIENT. 

  

	 	ix.	Except as set forth above, this Section X shall not limit any liability of HYALURON under Section XVI. 

  

 6 

	 	XI.	TERM AND TERMINATION 

  

	 	a.	Term 

  

	 	i.	This Agreement shall commence on the date first above written and will continue for a period of one year; provided that if a party provides notice to the other of its desire to
extend the term for an additional one year period no later than 75 days prior to the expiration of the then current one year term and the party receiving such notice does not reject such extension in writing within 15 days of receipt, the terms of
this Agreement shall extend for an additional on year period. HYALURON has manufactured and delivered the Drug Product batch(s) set forth on Exhibit II to CLIENT, provided that 

  

	 	b.	Termination 

  

	 	i.	This Agreement may be terminated at any time upon the occurrence of any of the following events: 

  

	 	1.	Default: forty-five (45) days written notice, by either party to the other party, in the event that the other party breaches any provision of this Agreement, and such party fails to
remedy the breach prior to the expiration of the forty-five (45) day period. 

  

	 	2.	Insolvency: Written notice by either party to the other upon the assignment for the benefit of creditors of the other party, if proceedings in voluntary or involuntary bankruptcy
are instituted against the other party or if a receiver or trustee is appointed for the other party, and the failure of such insolvency, bankruptcy or proceeding to be dismissed with sixty (60) days. 

  

	 	3.	Notice by Client: Following ninety (90) days written notice by CLIENT to HYALURON. 

  

	 	c.	Payment on Termination 

  

	 	i.	CLIENT shall be responsible for all Cancellation fees and penalties as described in Section IX. 

  

	 	ii.	Upon reimbursement, HYALURON shall send raw materials and components to CLIENT in accordance with CLIENT’S instructions. 

  

	 	d.	Survival 

  

	 	i.	Paragraph C of this Section XI and Sections XII, XIII, XIV and XVI shall survive the termination or cancellation of this Agreement for any reason. 

  

	 	XII.	WARRANTIES 

  

	 	a.	Compliance 

  

	 	i.	HYALURON shall manufacture all Drug Product and perform other work in accordance with cGMP Regulations as they apply to product for human clinical trial material.

  

	 	ii.	In manufacturing Drug Product, HYALURON shall take every commercially reasonable effort to comply with all applicable laws, regulations, and professional standards.

  

	 	iii.	CLIENT assumes responsibility for all contact with the FDA and other regulatory bodies, pertaining specifically to Drug Product. 

  

	 	iv.	HYALURON shall advise CLIENT immediately if an authorized agent of any regulatory body visits or inspects HYALURON manufacturing facility and makes an inquiry regarding
HYALURON’s method of manufacture of the Drug Product for CLIENT. 

  

	 	v.	HYALURON shall make available to CLIENT all correspondence, reports and notices received from, or sent to, the FDA or any other such regulatory body regarding any such visits,
inquiries or inspections related to the manufacture of the Drug Product for the CLIENT at HYALURON. 

  

 7 

	 	vi.	HYALURON shall notify CLIENT immediately upon receipt of any advance notice of any inspection by FDA specifically regarding the manufacture of CLIENT’S Drug Product, and CLIENT
shall have the right to have an employee present at any such inspection. 

  

	 	b.	Audits 

  

	 	i.	CLIENT shall have the right, upon fifteen (15) business days prior written notice for cause and (30) business days prior written notice for all other audits to HYALURON, to conduct
during normal business hours a quality assurance audit and examination of HYALURON’s records and production facilities relating to the production of CLIENT’S Drug Product and to perform follow-up audits as reasonably necessary.

  

	 	ii.	CLIENT shall have access only to the facilities and information that is deemed necessary to successfully complete this audit and examination while maintaining information
confidential pursuant to the provisions of Section XIII. 

  

	 	iii.	Such audits and examinations may be conducted from time to time on a reasonable basis with reasonable care to avoid undue interruptions to HYALURON’s business prior to
production of the first Drug Product batch ordered by CLIENT for 90 days after the first fill with HYALYRON and once a calendar year thereafter. 

  

	 	iv.	If CLIENT wishes to perform audits more often than provided under Section XII.b.iii., CLIENT shall pay HYALURON Five Thousand Dollars (US $5,000.00) per additional audit.

  

	 	v.	CLIENT shall have the right at any time during the term of this Agreement, upon five (5) business days prior written notice to HYALURON, to conduct any audits specifically mandated
by any Regulatory Authority or to respond to specific questions from any Regulatory Authority. 

  

	 	vi.	Visits by CLIENT to HYALURON’s aseptic filling facility involve maintaining the Confidential Information subject to the terms outlined in Section XIII.

  

	 	vii.	The results of any such audits and examinations shall be considered Confidential Information under Section XIII and shall not be disclosed to third parties. If CLIENT discloses
HYALURON audit information to regulatory agencies, CLIENT will notify HYALURON in writing of such communication if such disclosure is reasonably expected to initiate an audit by a regulatory agency. 

  

	 	viii.	If CLIENT utilizes auditors that are not employees of CLIENT, each of such auditors shall be subject to a non-disclosure agreement with HYALURON or CLIENT with confidentiality terms
at least as stringent as those set forth herein. 

  

	 	c.	Drug Product Recalls 

  

	 	i.	In the event: (i) any government authority issues a request, directive or order that the Drug Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or
(iii) CLIENT reasonably determines that the Drug Product should be recalled because the Drug Product does not conform to Specifications, the parties shall take all appropriate corrective actions. In no event, however, shall HYALURON have
responsibility for regulatory compliance in connection with any recall, except to the extent and under the circumstances as required by law. All costs and expenses incurred in connection with such recall shall be the responsibility of CLIENT unless
caused primarily by the negligence or willful misconduct of HYALURON or breach by HYALURON of the warranties set forth above or of any other term of this Agreement. 

  

	 	d.	Limitation of Remedies and Damages 

  

	 	i.	Except as set forth elsewhere herein, CLIENT’S sole and exclusive remedy for any claim arising by reason of or in connection with the sale, purchase, or delivery or use of Drug
Product, regardless of whether such claim is based on tort law, breach of contract, breach of warranty or any other legal theory shall be a return of the price for manufacturing of that specific lot of Drug Product. 

  

 8 

	 	ii.	Except as set forth elsewhere herein, under no circumstances shall either party be liable for loss of use, lost profits or any other collateral, special, consequential or other
incidental damages, losses, or expenses of the other party in connection with or by reason of any claim relating to the manufacture, supply, sale, purchase, use or delivery of Drug Product. 

  

	 	iii.	The foregoing warranties shall not extend to any nonconformity or defect, which relates to or is caused by Bulk Drug Substance or Active Pharmaceutical Ingredient or Bulk Formulated
Drug supplied by CLIENT. 

  

	 	XIII.	CONFIDENTIALITY 

  

	 	a.	HYALURON and CLIENT agree to treat any information obtained from the other party (the “Disclosing Party”) or from a third-party performing services for the Disclosing
Party in the course of the performance of this Agreement, and anything derived therefrom, including information generated in the course of performance of this Agreement, (collectively the “Information”) as the confidential and exclusive
property of the Disclosing Party. 

  

	 	b.	The party receiving such Information (the “Receiving Party”) agrees not to disclose any of the Information to any third-party without first obtaining the written consent
of the Disclosing Party. 

  

	 	c.	The Receiving Party agrees that it will use the Information for the purposes of satisfying its obligations under this Agreement, and for no other purpose without the prior written
consent of the Disclosing Party. 

  

	 	d.	The Receiving Party agrees to take all practicable steps to insure that the Information will not be used by its directors, officers, employees or consultants, except on like terms
of confidentiality as aforesaid, and will be kept fully private and confidential by them. 

  

	 	e.	Confidentiality shall not apply to that part of the Information which the Receiving Party is able to demonstrate by documentary evidence: 

  

	 	i.	was fully in the Receiving Party’s possession prior to receipt from the Disclosing Party or from a third-party performing services for the Disclosing Party; or

  

	 	ii.	was in the public domain at the time of the receipt form the Disclosing Party; or 

  

	 	iii.	became a part of the public domain through no fault of the Receiving Party, its directors, officers, employees or consultants; or 

  

	 	iv.	was lawfully received by the Receiving Party from some third-party having a right of further disclosure, other than an Affiliate of the Disclosing Party or a third party performing
services for the Disclosing Party; or 

  

	 	v.	is required to be disclosed by applicable law or regulation; provided, however, that in the event of a required disclosure, the Receiving Party shall promptly provide the Disclosing
Party with prompt notice of the required disclosure so that the Disclosing Party may have an opportunity to prevent the same. Upon Disclosing Party’s request, Receiving Party will use reasonable efforts to assist Disclosing Party to obtain
assurances that confidential treatment will be accorded to the Information disclosed pursuant to this Section XIII.e.v. Receiving Party shall give Disclosing Party written notice of any Information to be disclosed pursuant to this Section XIII.e.v.

  

	 	XIV.	INTELLECTUAL PROPERTY 

  

	 	a.	HYALURON shall promptly notify CLIENT of any invention, discovery, know-how or improvement which are conceived or made solely by one or more employees of HYALURON or jointly by one
or more employees of CLIENT during performance by HYALURON of its obligations under this Agreement. All Intellectual Property that is an improvement, or new use, of Bulk Drug Substance, Active Pharmaceutical Ingredient, Bulk Formulated Drug or Drug
Product; or an invention that embodies or is developed using Information furnished by CLIENT or a third party performing services for CLIENT is hereby referred to as “CLIENT Intellectual Property”. 

  

 9 

	 	b.	HYALURON hereby assigns to CLIENT all of HYALURON’s right to, and interest in, any CLIENT Intellectual Property. 

  

	 	c.	All intellectual property that is not CLIENT Intellectual Property (“HYALURON Intellectual Property”) shall be the sole and exclusive property of HYALURON.

  

	 	d.	HYALURON agrees to assist CLIENT in preparing and prosecuting patent applications and patent extensions or in obtaining other forms of intellectual property right protections on any
CLIENT Intellectual Property assigned to CLIENT under this Section XIV. which CLIENT elects to protect. 

  

	 	e.	HYALURON hereby irrevocably appoints CLIENT as HYALURON’s attorney-in-fact for the purpose of executing the documents in CLIENT’s name as may be necessary or desirable to
carry out the purposes of this Section XIV. 

  

	 	XV.	USE OF SUBCONTRACTORS 

  

	 	a.	HYALURON shall not assign, subcontract, or delegate any of its responsibilities under this Agreement without the prior express written consent of CLIENT. 

 

	 	XVI.	INDEMNIFICATION 

  

	 	a.	Indemnification by CLIENT 

  

	 	i.	CLIENT shall defend and indemnify and hold HYALURON and any parent, subsidiary, or affiliate entity and their officers, directors and the employees, and/or their successors and
assigns thereto (collectively, “HYALURON Indemnities”), free and harmless from any and all expenses associated therewith (including, without limiting the generality of the foregoing, reasonable defense costs and attorney’s fees), to
the extent arising out of or in connection with, or are the result of, or are otherwise related to: 

  

	 	1.	the promotion, distribution, use, misuse or sale of the Drug Product (including, without limiting the generality of the foregoing, any claims, express, implied or statutory, made as
to the efficacy or safety thereof); provided such expenses are not the result of the negligence or willful misconduct of HYALURON or any of its agent or employees or breach by HYALURON of any terms of this Agreement; including all Exhibits attached
hereto. 

  

	 	2.	any Drug Product labeling or packaging; 

  

	 	3.	CLIENT’S non-compliance with any applicable Federal or State law or regulation; or 

  

	 	4.	any failure of CLIENT to perform, in whole or in part, any of its obligations hereunder except in each case to the extent caused by the acts or omissions of HYALURON including the
negligence or willful misconduct of HYALURON or any of its agents or employees or breach by HYALURON of any terms of this Agreement, including all Exhibits attached hereto. 

  

	 	ii.	CLIENT also will indemnify and hold HYALURON Indemnities free and harmless against any and all claims, demands, liability, actions or causes of action, and any and all expenses
associated therewith (including without limiting the generality of the foregoing, reasonable defense costs and attorney’s fees), for damages on account of personal injury (including death) or property damage to the extent arising out of or in
connection with the CLIENT’S alteration, secondary processing or handling of the Drug Product. 

  

	 	b.	Indemnification by HYALURON 

  

	 	i.	HYALURON will indemnify and hold CLIENT and any parent, subsidiary or affiliate entity and their officers, directors and employees and/or their successors and assigns thereto, free
and harmless from any and all claims, demands, liability, actions or causes of action, or any fines or penalties, and any and all expenses associated therewith (including without limiting the generality of the foregoing, reasonable defense

  

 10 

 costs and attorney’s fees) to the extent arising out of or in connection with the negligence or
willful misconduct of HYALURON or any of its agents or employees or breach by HYALURON of any term of this Agreement including all Exhibits attached hereto. 
  

	 	XVII.	GENERAL PROVISIONS 

  

	 	a.	Notices 

  

	 	i.	Any notice permitted or required by this Agreement may be sent by facsimile with the original document being sent by certified (or registered) mail, return receipt requested, or
overnight delivery and shall be effective when received (or refused) via facsimile or mail or overnight if sent to the address below (or to such other facsimile number or address as may be designated by a party in writing): 

 

			
	CLIENT	  	HYALURON
	 GlycoGenesys, Inc
 31 St. James Avenue
 Boston, MA 02116
 Attention: Michael Koch
 Fax: 617-422-0675
	  	 Hyaluron, Inc.
 99 South Bedford Street
 Burlington, MA 01803
 Attention: Andrea Wagner
 Fax: 781-270-0110

  

	 	b.	Entire Agreement; Amendment 

  

	 	i.	The parties hereto acknowledge that this Agreement sets forth the entire agreement and understanding of the parties and supersedes all prior written or oral agreements or
understanding with respect to the subject matter hereof. 

  

	 	ii.	No modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to be valid unless in writing and signed by both parties hereto.

  

	 	iii.	No course of dealing or usage of trade shall be used to modify the terms and conditions herein. 

  

	 	iv.	Any changes and modifications to this Agreement, including scheduling changes shall be approved by both parties and added to Exhibit VI. 

  

	 	v.	No failure or delay in exercising any remedy under this Agreement shall operate as a waiver hereof, nor shall any single or partial exercise thereof preclude any other or further
exercise thereof or the exercise of any other remedy. 

  

	 	vi.	In the event any court shall determine that any term or provisions of this Agreement is invalid, such determination shall not affect the validity of the remaining terms or
provisions of this Agreement, which shall remain in full force and effect. 

  

	 	c.	Assignment 

  

	 	i.	This Agreement shall be binding upon and inure to the benefit of the successors or permitted assigns of each of the parties and may not be assigned or transferred by either party
without the prior written consent of the other, except that no consent shall be required in the case of a transfer to a wholly-owned subsidiary. 

  

	 	d.	Governing Law 

  

	 	i.	This Agreement is subject to and shall be governed by the laws of the Commonwealth of Massachusetts. 

  

 11 

 Agreed to and Accepted By: 
  

			
	FOR: HYALURON, Inc.	  	FOR: GLYCOGENESYS, Inc.
		
	 /s/ Shawn Kinney

	  	 /s/ Bradley J Carver

	Signature	  	Signature
		
	 Shawn Kinney

	  	 Bradley J Carver

	Printed Name	  	Printed Name
		
	 President

	  	 President and CEO

	Title	  	Title
		
	 1/12/05

	  	 1/14/05

	Date Signed	  	Date Signed

  

 12 

 EXHIBIT I 
  

PRODUCT SPECIFICATIONS 
  

							
	 Test

	  	 Method

	  	 Specification

	  	 Performed By

	Bulk Drug Substance	  	 	  	 	  	 
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	Bulk Formulated Drug	  	 	  	 	  	 
	 N/A
	  	 	  	 	  	 
	Bulk Drug Product	  	 	  	 	  	 
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	Drug Product	  	 	  	 	  	 
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	[*****]	  	 	  	Hyaluron
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	 	  	[*****]	  	[*****]
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	[*****]	  	[*****]	  	Hyaluron
	 [*****]
	  	 	  	[*****]	  	[*****]
	 [*****]
	  	 	  	[*****]	  	[*****]
	 [*****]
	  	 	  	[*****]	  	[*****]
	 [*****]
	  	 	  	XXXXX	  	[*****]
	 [*****]
	  	 	  	XXXXX	  	[*****]
	 [*****]
	  	 	  	XXXXX	  	[*****]
	 [*****]
	  	 	  	XXXXX	  	[*****]

 *[*****]    will be removed from
the product testing scheme after the completion of three successful batches. 
  
  

 13 

 EXHIBIT II 
  

PRICING and SCHEDULING 
  
 Reference Hyaluron Project Proposal 115 
  
 Revision #2 
  
 Issued: Wednesday, November 03, 2004 
  
 Project
Title: Manufacture of Phase I-III Clinical Supplies of GCS-100 
  

									
	 Drug Product

	  	Estimated Batch Size

	 	Pricing

	 	Tentative Fill Date

	 	Tentative Release Date

	 GCS-100LE
	  	[*****]	 	$[*****]	 	[****]	 	N/A
	 GCS-100LE
	  	[*****] vials	 	$[*****]	 	[****]	 	[****]
	 GCS-100LE
	  	[*****] vials	 	$[*****]	 	[****]	 	[****]
	 GCS-100LE
	  	[*****] vials	 	$[*****]	 	[****]	 	[****]
	 GCS-100LE
	  	[*****] vials	 	$[*****]	 	[****]	 	[****]

  

							
	 Activity

	  	Price

	 	Date

	 	Notes

	Media Fills	  	N/A	 	[*****]	 	SOP to be reviewed by
GlycoGenesys
	Analytical Suitability Testing	  	$[*****]	 	[*****]	 	 
	Batch Record/ Documentation Package	  	$[*****]	 	[*****]	 	 
	Cleaning Validation	  	$[*****]	 	[*****]	 	 

  

 14 

 EXHIBIT III 
  
 COMPONENTS 
  

											
	   Description  

	  	Size

	  	Manufacturer

	  	Manufacturer
Number

	  	Hyaluron
Number

	  	GlycoGenesys
Number

	Type I clear glass vial, Borosilicate	  	20mL	  	West
Pharmaceutical	  	 	  	400-100-006	  	N/A
						
	Stopper	  	20mm	  	West
Pharmaceutical	  	 	  	400-404-007	  	N/A
						
	Seal	  	20mm	  	West
Pharmaceutical	  	54202056	  	400-300-003	  	N/A
						
	Sterilizing Filters	  	 	  	Millipore	  	MPGL20CB3	  	100-020-012	  	N/A
						
	Tubing	  	 	  	 	  	 	  	100-021-025	  	N/A
						
	Fluid Handling Bags	  	 	  	 	  	 	  	100-029	  	N/A

  
 FILLING TOLERANCES

  

			
	   Values  

	  	Volume

	 Label Claim
	  	20mL
		
	 Target Fill Values
	  	20.5mL
		
	 Fill Tolerances
	  	20 to 21mL

  

 15 

 EXHIBIT IV 
  

QUALITY CONTROL TESTING PERFORMED AT HYALURON 
  

			
	 Test

	  	Acceptance Criteria

	Bulk Drug Substance	  	 
	 [*****]
	  	[*****]
	 [*****]
	  	[*****]
	Bulk Formulated Drug	  	 
	 N/A
	  	 
	Bulk Drug Product	  	 
	 [*****]
	  	[*****]
	Drug Product	  	 
	 [*****]
	  	[*****]
	 [*****]
	  	[*****]
	 [*****]
	  	[*****]
	 [*****]
	  	XXXXX
	 [*****]
	  	[*****]
	 [*****]
	  	[*****]
	 [*****]
	  	[*****]

  
 RETAINS

  
 Bulk Drug Substance 
 XXXXXmL 
  
 Bulk Formulated Drug 
 XXXXXmL 
  
 Bulk Drug Product    XXXXXmL 
  
 Final Drug Product    XXXXX vials 
  

 16 

 EXHIBIT V 
 AUTHORIZATION LETTER 
 Page 1 of 2 
  
 Date:                     

  
 HYALURON, Inc. 
 99 South Bedford Street 
 Burlington, MA 01803 
 Attentiion: Myron Dittmer 
  
 Mr. Dittmer:

  
 Pursuant to the Drug Manufacturing Agreement dated December 30, 2004, CLIENT
(GlycoGenesys, Inc.), authorizes HYALURON, Inc. to perform the following services: 
  

			
	 General Information:
	 	 
		
	 Product to be Filled:
	 	  
 _____________________________

	 Batch Number Assigned:
	 	  
 _____________________________

	 Expected batch Size:
	 	  
 _____________________________

	 Dosage Unit:
	 	  
 _____________________________

	 Anticipated Deliver Date:
	 	  
 _____________________________

		
	 Services Required:
	 	 
	 	 	                    Initial Below
	 Aseptic Filling:
	 	  
 _____________________________

	 100% Visual Inspection:
	 	  
 _____________________________

	 QC Testing:
	 	  
 _____________________________

	 Stability Studies:
	 	  
 _____________________________

	 Other (list):
	 	  
 _____________________________

	 	 	  
 _____________________________

	 Disposal:
	 	  
 _____________________________

	 Sample Retention/Storage:
	 	  
 _____________________________

  

 17 

 EXHIBIT V 
 AUTHORIZATION LETTER 
 Page 2 of 2 
  
 Filling Tolerances and Information (To be defined prior to fill): 
  

			
	 Values:
	 	  
 _____________________________

	 Volume:
	 	  
 _____________________________

	 Weight:
	 	  
 _____________________________

	 Label Claim:
	 	  
 _____________________________

	 Target Fill Values:
	 	  
 _____________________________

	 Fill Tolerance:
	 	  
 _____________________________

	 Specific Gravity:
	 	  
 _____________________________

  
 Price: (See Exhibit II of the
Agreement) 
  
 If you agree to the above information please sign and return one
copy of this letter to the undersigned. 
  

			
	FOR: HYALURON, Inc.	  	FOR: GLYCOGENESYS, Inc.
	  

 Signature
	  	  

 Signature

	  

 Printed
Name
	  	  

 Printed
Name

	  

 Title
	  	  

 Title

	  

 Date
Signed
	  	  

 Date
Signed

  

 18 

 EXHIBIT VI 
 CONTRACT AMENDMENT HISTORY 
  

 19

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