Document:

lmnl-ex425_363.htm

 

Exhibit 4.25

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE LIMINAL BIOSCIENCES INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO LIMINAL BIOSCIENCES INC. IF PUBLICLY DISCLOSED.

 

MASTER ServIces AGREEMENT

THIS MASTER SERVICES AGREEMENT is entered into as of this 15th day of May, 2015 (the “Effective Date”), by and between ProMetic Life Sciences, Inc. (“CUSTOMER”), having an address at 440 Armand-Frappier Boulevard, Suite 300, Laval, Quebec, H7V 4B4, Canada, and Cangene Corporation doing business as Emergent BioSolutions (“EMERGENT”), an Ontario corporation having an address at 155 Innovation Drive, Winnipeg, Manitoba, R3T 5Y3 Canada, with respect to the following:

RECITALS

WHEREAS, CUSTOMER is in the business of developing and commercializing drug products, specifically plasma-derived proteins extracted from human donor plasma using Customer’s proprietary PPPSTM technology;

WHEREAS, EMERGENT is in the business of developing and manufacturing products derived from human donor plasma;

WHEREAS, CUSTOMER wishes to engage Emergent to perform Services (as hereafter defined) using EMERGENT’s Manufacturing Facility (as hereafter defined) and Customer’s proprietary PPPS technology in order to expand CUSTOMER’s processing capacity for the Products (as hereafter defined);

WHEREAS EMERGENT is willing to perform such Services as requested by CUSTOMER and agreed to by EMERGENT from time to time;

WHEREAS, CUSTOMER and EMERGENT desire to enter into this Agreement in order to establish the terms and conditions under which EMERGENT will perform the Services relating to the Products (as hereafter defined); and

NOW THEREFORE, in consideration of the premises and the mutual promises and covenants contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

ARTICLE I
DEFINITIONS

All references to particular Exhibits, Sections and Articles, shall mean the Exhibits to, Sections of, and Articles of, this Agreement, unless otherwise specified.  For the purposes of this Agreement, the following words and phrases shall have the following meanings.

1.1“2015 Forecast” has the meaning set forth in Section 4.1.1.

 

1

 

 

 

 

1.2“Affiliate” means, with respect to either Party, any present or future legal entity that, directly or indirectly through one or more intermediate legal entities, controls, is controlled by, or is under common control with such Party. For purposes of this definition, “Control” means (i) more than fifty percent (50%) of the outstanding voting stock of a corporation, (ii) more than fifty percent (50%) of the equity of a limited liability company, partnership or joint venture, (iii) a general partnership interest in a partnership or joint venture, or (iv) the power, direct or indirect, to direct or cause the direction of the management and policies of the controlled entity, whether through the ownership of voting equity interests in the entity, through contract or otherwise.

1.3“Additional Personnel” has the meaning set forth in Section 4.1.3(b).

1.4“Additional Services” means services requested by the CUSTOMER under this Agreement other than the Base Manufacturing Services (which could include any or all of the Non-Bulk Manufacturing Services).  

1.5“Additional Time” has the meaning set forth in Section 4.1.3(b).

1.6“Agreement” means this Master Services Agreement, including any exhibits and schedules.

1.7 “Applicable Laws” means [***] 

1.8“Applicable Taxes” has the meaning set forth in Section 6.6. 

1.9“Arbitrator Panel” has the meaning set forth in Section 13.7.

1.10“Arising Inventions” means any and all improvements and inventions (whether or not patentable) made by either Party during the term of this Agreement and arising out of the performance of the Services or that are otherwise related thereto.  For clarity, inventions made by either Party during the term of this Agreement that do not arise out of the provision of services or the collaborative work of the parties related to the provision of the Services shall not be Arising Inventions.

1.11“Background Emergent IP” means any and all Intellectual Property rights owned or controlled by EMERGENT and its Affiliates as of the Effective Date, including its rights in its Confidential Information.

1.12“Background Customer IP” means any and all Intellectual Property rights owned or controlled by CUSTOMER and its Affiliates as of the Effective Date, including inter alia, CUSTOMER’s Technology, Products and its rights in its Confidential Information.

1.13“Base Manufacturing Services” means [***].  

1.14“Base Personnel” means [***]

1.15“Base Personnel Allocation” means [***] 

1.16“Batch” means [***]

1.17“Batch Record” means [***]

 

2

 

 

 

 

1.18 “Bulk Manufacturing Services” mean [***]

(i) (ii) [***]

(iii) [***]

(iv) {***]

(v) [***] 

(vi) [***]

(vii) [***] 

(viii) [***] 

(ix) [***] 

(x) [***]

(xi) [***]

[***]

1.19“CDE PM Program” has the meaning set forth in Section 4.8.

1.20“Certificate of Analysis” means the document for each Batch of the Product prepared by EMERGENT, reporting the results of testing conducted by EMERGENT.

1.21 “CFR” means the United States Code of Federal Regulations.

1.22“Confidential Information” means any non-public information, technical data, trade secrets or know-how, including, but not limited to, that which relates to research, products, services, customers, markets, software, developments, inventions, processes, standard operating procedures, designs, drawings, engineering, marketing, contracts, pricing or finances.  “Confidential Information” does not include information, technical data or know-how that (i) prior to or after the time of disclosure, becomes part of the public knowledge, not as a result of any inaction or action of the Receiving Party; (ii) is approved by the Disclosing Party, in writing, for release; (iii) was received by the Receiving Party from a third party having a right to disclose it and which was not subject to an obligation of confidentiality owed to the third party at the time of disclosure; (iv) is developed by or for the Receiving Party independently of disclosures hereunder, as shown by written records; or (v) the Receiving Party is compelled to disclose by a court or tribunal of competent jurisdiction. 

1.23 “[***]” has the meaning set forth in Section 13.6.2.

1.24“Covered Transaction” has the meaning set forth in Section 13.6.1.

1.25“Current Good Manufacturing Practices” or “GMP” or “cGMP” means current good manufacturing practice and pharmaceutical industry standards as provided for (and as amended from time to time) in Part C, Division 2 of the Food and Drug Regulations (Canada) and in the U.S. Code of Federal Regulations Title 21 (21 CFR §§ 210 and 211).

1.26“Customer Arising IP” has the meaning set forth in Section 10.9.

1.27“Customer Dedicated Equipment” has the meaning set forth in Section 4.6.

 

3

 

 

 

 

1.28“Customer-Provided Materials” has the meaning set forth in Section 4.3.

1.29“Customer’s Technology” means the following technology:

(i) any one of the [***]

(ii) [***]

(iii) [***]

(iv) [***]

(v) [***]

(vi) [***]

1.30“Development Activities” [***]

1.31 “Disclosing Party” means a Party to this Agreement who discloses Confidential Information to the other Party to this Agreement.

1.32“Effective Date” has the meaning set forth in the Preamble.

1.33“Emergent Arising IP” has the meaning set forth in Section 10.9.

1.34“[***]” has the meaning set forth in INCOTERMS 2010.  

1.35“FDA” means the United States Food and Drug Administration.

1.36“Forecast” shall mean the 2015 Forecast, the Initial 24 Month Forecast and/or each Rolling Forecast, as the context requires.

1.37“FTE Cost” has the meaning set forth in Section 6.3.1.2.

1.38“Governmental Authority” means any (a) nation, state, county, city, town, village, district or other jurisdiction of any nature; (b) federal, state, provincial, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental agency, branch, department, official or entity and any duly authorized court or other tribunal, including an arbitral tribunal); (d) multi-national organization or body; or (e) body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory or taxing power of any nature.

1.39“Health Canada” means the department of the Government of Canada with responsibility for national public health.

1.40“[***]” has the meaning set forth in Section 13.6.1.

1.41“Impairment” has the meaning set forth in Section 7.4.1. 

1.42“Indemnified Party” has the meaning set forth in Section 9.3.1.

1.43“Indemnifying Party” has the meaning set forth in Section 9.3.1.

 

4

 

 

 

 

1.44“Initial 24 Month Forecast” has the meaning set forth in Section 4.1.2.

1.45“Initial Term” has the meaning set forth in Section 11.1.

1.46“Insolvency/Bankruptcy Event” shall be deemed to have occurred if a Party: (a) voluntarily consents to an order for relief by filing a petition for relief under any bankruptcy or insolvency laws of any jurisdiction; (b) seeks, consents to or does not contest the appointment of a receiver, custodian or trustee for itself or for all or any part of its property; (c) files a petition seeking relief under the bankruptcy, arrangement, reorganization or other debtor relief laws of any competent jurisdiction; (d) admits in writing that it is generally not paying its debts as those debts become due; (e) gives notice to any governmental body of insolvency or pending insolvency; (f) suspends material business operations; (g) becomes “Insolvent” as that term is defined under applicable fraudulent transfer or conveyance laws or comparable foreign laws; or (h) makes an assignment for the benefit of creditors or takes any other similar action for the protection or benefit of creditors. 

1.47“Intellectual Property” or “IP” means all intellectual property rights, anywhere in the world, including rights to (i) inventions (whether patentable or not, and whether or  not reduced to practice), and all improvements thereto; (ii) patents and patent applications, including any patents issued from such applications and any divisions, continuations, continuations-in-part, re-issues, re-examinations, patents of addition, extensions and foreign counterparts to any of the foregoing; (iii) copyrights; (iv) designs and industrial designs; (v) trademarks, service marks, logos, trade names and corporate names, together with all adaptations, translations, derivations, and combinations thereof (including all goodwill associated therewith); (vi) Confidential Information, including know-how and trade secrets; (vii) integrated circuit topographies; and (viii) any applications for the registration and protection of any of the foregoing;

1.48"Laws" means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Governmental Authority;

1.49“Lawsuit” has the meaning set forth in Section 8.4.

1.50“Lawsuit Related Claim” has the meaning set forth in Section 9.3.2.

1.51“Manufacturing” means [***]

1.52“Manufacturing Date” means [***]

1.53“Manufacturing Facility” means EMERGENT’s premises and equipment located [***] at 155 Innovation Drive, Winnipeg, Manitoba, R3T 5Y3 as well as all other related infrastructures located at 155 Innovation Drive, [***].

1.54“Master Batch Record” means a master production and control record containing a written description of the procedure to be followed for Manufacturing a Batch of Product including but not limited to a complete list of all active and inactive ingredients, components, weights and measures, descriptions of drug product containers, closures, packaging materials, and labeling and complete specifications for each, within the meaning of 21 CFR part 211.186, or its successor as in effect from time to time. 

1.55“Material Terms” has the meaning set forth in Section 13.6.1.

 

5

 

 

 

 

1.56“Materials” means all raw materials and other items consumed during the performance of the Services, inactive ingredients, chemicals, folding cartons and/or shipping cartons as are otherwise necessary to be utilized in the Manufacturing and to meet the Specifications, [***]. 

1.57“Minimum Annual Payment” means [***]   

1.58“MSDS” means Materials Safety Data Sheet.

1.59 “NAT” means nucleic acid testing.

1.60“Non-Bulk Manufacturing Services” means any and all services that do not qualify as Bulk Manufacturing Services, [***]

1.61“[***]” has the meaning set forth in Section 13.6.1.

1.62“[***]” has the meaning set forth in Section 13.6.1.

1.63“Parties” means EMERGENT and CUSTOMER collectively.

1.64“Party” means either EMERGENT or CUSTOMER. 

1.65“Plasma” means human plasma collected from donors and treated in accordance with the requirements of the Quality Agreement.

1.66“Plasma Specifications” means the specifications and specific requirements with respect to the Plasma as set forth in Exhibit B attached hereto. 

1.67“Product(s)” means the proteins extracted from Plasma using Customer’s proprietary PPPSTM technology, as further set forth in Exhibit C and as amended from time to time by the Parties in writing.

1.68“Project Manager” has the meaning set forth in Section 3.2.

1.69“[***]” has the meaning set forth in Section 13.6.1.

1.70“Prorated 2015 Reserved Time” has the meaning set forth in Section 4.1.1.

1.71“Purchase Commitment” has the meaning set forth in Section 6.9. 

1.72“Purchase Order” means a document issued and signed by CUSTOMER, ordering Services from EMERGENT according to the provisions of this Agreement.  The Purchase Order will include (a) the Services being ordered pursuant to the applicable Statement of Work; (b) if applicable, the number of Batches ordered; (c) the date agreed upon for Services to be performed in accordance with a Statement of Schedule and any agreed target delivery dates; and (d) the agreed upon price for Additional Services to be performed pursuant to such Purchase Order.  If any terms or requirements are written onto the Purchase Order that are in addition to or in conflict with the Statement of Work, the Statement of Schedule or the terms of this Agreement, such additional or conflicting terms are of no force and effect and are superseded by the terms and requirements of this Agreement.     

 

6

 

 

 

 

1.73“Quality Agreement” means the Manufacturing Quality Agreement between CUSTOMER and EMERGENT for the Products, which when fully executed will be attached hereto as Exhibit D, which specifies the respective responsibilities for quality control and quality assurance activities consistent with cGMPs with respect to the Manufacture of Product and with respect to Customer Provided Materials (including Plasma).

1.74“Quality Assurance Department” means the department within EMERGENT responsible for quality assurance matters.

1.75“Receiving Party” means a Party to this Agreement who receives Confidential Information from the other Party to this Agreement.

1.76“Regulatory Approvals” means [***]

1.77“Regulatory Authority” means Health Canada, the FDA, or any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign, that performs a function for such political subdivision similar to the function performed by Health Canada for Canada and the FDA for the United States.

1.78“Regulatory Materials” means regulatory applications, submissions, notifications, registrations, Regulatory Approvals and/or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to study, manufacture, market, distribute, sell and/or import a Product in a particular country or jurisdiction of the Territory.  

1.79“Regulatory Standards” [***]

1.80“Release Date” means the date on which all Release Documents have been signed by EMERGENT and submitted to CUSTOMER in accordance with Section 5.3 and the Product is ready to be shipped.

1.81“Release Documents” means the following documents: (a) EMERGENT’s Certificate of Analysis for each Batch of Product, and (b) such other documents deliverable by EMERGENT in connection with release of Product as specified in the Quality Agreement.

 

1.82“Renewal Term” has the meaning set forth in Section 11.1.

1.83“Representative” has the meaning set forth in Section 10.1.

1.84“Reserved Time” means [***]

1.85“[***]” has the meaning set forth in Section 13.6.2

1.86“[***]” has the meaning set forth in Section 13.6.2.  

1.87“[***]” has the meaning set forth in Section 13.6.1.

1.88“[***]” has the meaning set forth in Section 13.6.1.

1.89“[***]” has the meaning set forth in Section 13.6.1.

 

7

 

 

 

 

1.90 “Rolling Forecast” has the meaning set forth in Section 4.1.2.

1.91“Services” means the Base Manufacturing Services and Additional Services as set forth in a Statement of Work;

1.92“Shipping Specifications” has the meaning set forth in Section 5.1.

1.93“Specifications” means (a) the Product specifications as set forth in the Master Batch Record and (b) the Shipping Specifications.

1.94“Statement of Work” means a binding written work order, accepted in writing by both Parties and setting forth the scope of Services to be performed by EMERGENT, substantially in the form set forth in Exhibit X hereto.

1.95 “Statement of Schedule” means a binding written document, mutually accepted in writing by both Parties, which lays out the specific dates upon which Services will be conducted, substantially in the form set forth in Exhibit Y hereto.

1.96“Tech Transfer Activities” means [***]  

1.97“Term” has the meaning set forth in Section 11.1.

1.98“Territory” means the world.

1.99“Transferred Assets” has the meaning set forth in Section 13.6.1.

ARTICLE II
GENERAL TERMS 

2.1Master.  This Agreement is intended to serve as the framework for the Parties to contract for Services associated with multiple Products.  

2.2Manufacturing Location.  Subject to the terms and conditions of this Agreement, EMERGENT agrees that it shall perform Services at the Manufacturing Facility.

2.3Master Batch Record.  EMERGENT shall prepare and maintain a Master Batch Record for each Product.  Each Master Batch Record shall be submitted by EMERGENT to CUSTOMER for review and approval and EMERGENT will not commence Manufacturing until the CUSTOMER gives its approval signature on the Master Batch Record for such Product.  EMERGENT will not make any changes to an approved Master Batch Record without obtaining CUSTOMER’s prior written approval.

2.4Import and Export.  [***] 

2.5Regulatory Filings and Inspections/Audits.   [***]

ARTICLE III
SERVICES

 

8

 

 

 

 

3.1Services. EMERGENT shall perform the Services in accordance with the terms of this Agreement and the Master Batch Record, if applicable. [***]

3.2Project Management.  CUSTOMER will keep EMERGENT informed with respect to the continued development of the Products.  Each Party shall appoint one contact person to serve as their project manager (the “Project Manager”) to receive all project management related communications pursuant to this Agreement and manage all aspects of the relationship, including Development Activities, Tech Transfer Activities, Manufacturing and regulatory status and timelines.  [***]     

ARTICLE IV
PURCHASE AND SUPPLY

4.1Purchases. 

4.1.12015 Forecast.  [***]

4.1.2Initial [***] & Rolling Forecasts.  [***]

4.1.3[***] Forecasts. 

(a)Within [***]of submission of the Initial 24 Month Forecast and each Rolling Forecast, the Parties shall discuss and mutually agree in writing, via a Statement of Work, on the scope of Services to be performed by EMERGENT during the [***]  

Identifying & Performing Additional Services.   [***] of submission of a Forecast, the Parties will assess [***] (c)Within [***]of both Parties signature of each Statement of Work entered into by the Parties pursuant to (a) above, the Parties shall discuss and mutually agree in writing, via a Statement of Schedule, upon the schedule for the Services to be performed [***] (d)Months [***]of each Rolling Forecast are for information and planning purposes only and are non-binding on both Parties.

4.1.4[INTENTIONALLY LEFT BLANK]    

4.1.5[***]4.1.6Statements of Work & Purchase Orders. All Services must be memorialized in a Statement of Work and if applicable, a Statement of Schedule.  Once the Parties have signed a Statement of Work and, if applicable a Statement of Schedule, CUSTOMER shall issue a Purchase Order(s) for the Services covered by a Statement of Work and, if applicable, such Statement of Schedule.

 

4.2Underutilization and Cancellation.  

4.2.1[***]4.2.2[***]4.2.3Cancellations.  CUSTOMER shall provide written notice to EMERGENT of its intent to cancel Services set forth in a Statement of Work 

 

9

 

 

 

 

and/or scheduled in a Statement of Schedule, (such notice a “Cancellation Notice”) as soon as reasonably practicable.  In the event of a change to or cancellation of Services, [***]

4.3 CUSTOMER-Provided Materials.  [***]

4.4  Manufacturing.  EMERGENT shall Manufacture the Product and perform the Services at the Manufacturing Facility in accordance with the Master Batch Record, any and all Applicable Laws, cGMPs, and the Quality Agreement.  Once approved by CUSTOMER as final, EMERGENT shall not make any changes to the Master Batch Record without the prior written approval of CUSTOMER.  The Product shall not be Manufactured and the Services shall not be performed at a facility other than at the Manufacturing Facility without the prior written consent of CUSTOMER.  [***]

4.5Timing of Manufacturing.  [***]   

4.6Purchase of Customer Dedicated Equipment.  [***]

4.7Ownership and Use of Customer Dedicated Equipment.  [***] 

 

 

4.8Customer Dedicated Equipment Preventive Maintenance Program

.   EMERGENT and CUSTOMER shall develop and implement by mutual agreement, a preventive maintenance program, [***], for the Customer Dedicated Equipment (the “CDE PM Program”). [***]The CDE PM Program will be designed in compliance with Applicable Laws, the Quality Agreement, and any other written understanding mutually agreed upon between the Parties.  Except for the qualification, validation and calibration in connection with the Tech Transfer Activities which are part of the Bulk Manufacturing Services, the CDE PM Program shall be considered Non-Bulk Manufacturing Services and the fees for the CDE PM Program shall be set forth in Exhibit F.  EMERGENT shall maintain an inventory of spare parts for such Customer Dedicated Equipment, as mutually agreed by the Parties as part of the CDE PM Program and paid for by the CUSTOMER.

 

4.9Removal

 of Customer Dedicated Equipment.  [***]

ARTICLE V

PRODUCT RELEASE; STORAGE

 

5.1Shipping Specifications.  [***], EMERGENT will provide CUSTOMER with proposed specifications for packaging and shipping the Product (including any technical and controlled-temperature requirements for delivery of the Product provided by CUSTOMER), which specifications will become effective upon written acceptance by CUSTOMER (“Shipping Specifications”).

 

10

 

 

 

 

5.2General Labeling.  To the extent the Services include Product labeling, CUSTOMER shall provide EMERGENT with labeling specifications which shall include, but not be limited to [***]. To the extent CUSTOMER’s labeling specifications include any trademark or service mark of CUSTOMER, [***]  All labeling specifications submitted by CUSTOMER shall comply with all applicable Regulatory Standards.  EMERGENT shall not affix any other labeling to the Product, except with the prior written approval of CUSTOMER. Notwithstanding EMERGENT’s acceptance of CUSTOMER’s labeling specifications, [***] 

5.3Release Documents.  [***], EMERGENT shall prepare the Release Documents specific to each Batch of Product, and shall submit them [***]to CUSTOMER or CUSTOMER’s designated representatives [***] Release Documents as specified in the Quality Agreement and applicable Materials and CUSTOMER-Provided Materials test results and results of environmental monitoring [***] Each shipment of Product will be accompanied by the Release Documents, as required under the Quality Agreement, including a Certificate of Analysis or, as applicable, a Material Safety Data Sheet, attesting to the compliance of each Batch with all Specifications.  CUSTOMER shall be responsible for the final release of Product for use in a clinical trial and/or commercial sale.  

5.4Storage, Use and Segregation of Plasma, CUSTOMER-Provided Materials, and Product.  EMERGENT shall label and store all Plasma, CUSTOMER-Provided Materials, and Product in its possession from the time of delivery to EMERGENT at the Manufacturing Facility or upon completion of Manufacture, until delivery of the Product to the carrier designated by CUSTOMER in accordance with this Article V, all Regulatory Standards, and any storage instructions provided by CUSTOMER.  EMERGENT shall ensure that all Plasma, CUSTOMER-Provided Materials and stocks of Product are clearly identified as CUSTOMER property and kept separate and distinguished from stocks and supplies held by EMERGENT in connection with manufacturing or packaging for itself or its other customers.  EMERGENT shall store or otherwise dispose of Product, Plasma and/or CUSTOMER-Provided Materials pursuant to CUSTOMER’s written instructions; provided however, that EMERGENT may dispose of Product, Plasma and/or CUSTOMER-Provided Materials pursuant to Section 5.6 below.     

5.5Storage Fee. Subject to the adjustments set forth in this Section 5.5 and any applicable adjustments pursuant to Section 6.8, [***]Disposal and/or Maintenance of Plasma, Product and Customer Provided Materials.  Except as necessary for Manufacturing or as otherwise required under this Agreement, EMERGENT shall not dispose of any Plasma, CUSTOMER-Provided Materials or Product in any form or at any stage of Manufacturing or thereafter without the prior written approval of CUSTOMER.  EMERGENT shall maintain and keep complete and accurate documentation of all validation data, stability testing data, Batch Records, quality control and laboratory testing and any other data required under cGMPs in compliance with Applicable Laws and EMERGENT’s standard operating procedures.  Notwithstanding the foregoing, EMERGENT may return or destroy Plasma, CUSTOMER-Provided Materials, Product, and/or documentation in accordance with Applicable Laws in the event that [***], provided that EMERGENT has given CUSTOMER written notice of its intent to dispose of such items, [***]

ARTICLE VI

PRICE & TERMS OF PAYMENT

 

 

11

 

 

 

 

6.1Minimum Annual Payment.  [***]   

6.2Adjustments to the Minimum Annual Payment.  [***]

6.2.1[***]

 

	

	
6.2.2[***]

6.3Pricing Additional Services.  

6.3.1e: [***]

6.3.1.1[***]

 

6.3.1.2[***]

6.3.1.3[***]

 

6.3.2[***]  

6.4The price for all Services is exclusive of all:

(i)Applicable Taxes, pursuant to Section 6.6 below,

(ii)[***]

(iii)[***]

6.5Invoices. [***] Payments shall be rendered by CUSTOMER within thirty (30) days from the invoice issuance date.  If an undisputed payment is not paid in full in accordance with this Agreement, CUSTOMER shall pay interest on such amount in default at a monthly rate of [***].       

6.6Applicable Taxes. Any payment due under this Agreement by the CUSTOMER to EMERGENT is exclusive of taxes, including without limitation, any goods and services tax, sales tax, value added taxes, turnover taxes, and/or any other taxes, duties, or levies, including any related interest and penalties that may relate to the Services provided hereunder ("Applicable Taxes").  Applicable Taxes will be added to the invoice amount and will be for the account of and reimbursable to EMERGENT by the CUSTOMER.

 

6.7[***].  All prices are [***]

 

6.8[***]  

 

 

6.9Purchase Commitment.  CUSTOMER agrees that:

 

12

 

 

 

 

 

(i)during each calendar year between [***], the aggregate of the Minimum Annual Payment and amount invoiced to CUSTOMER for Additional Services performed during such calendar year,  shall total [***]; and

(ii)during each calendar year between [***], the aggregate of the Minimum Annual Payment and amount invoiced to CUSTOMER for Additional Services performed during such calendar year,  shall total [***]

In the event that CUSTOMER does not achieve its purchase commitment as set forth above in any particular calendar year (the “Purchase Commitment(s)”), and such failure is not directly caused by: (a) wrongful acts or omissions of EMERGENT or acts or omissions of EMERGENT in breach of this Agreement; (b) EMERGENT’s failure to accommodate Additional Services during the Reserved Time pursuant to Section 4.1.3(b); (c) a change to a Statement of Work,  a Statement of Schedule or to a target delivery date that was requested by EMERGENT or a delay in the performance of the Services that is caused by EMERGENT’s acts or omissions; (d) EMERGENT failing to perform its obligations under this Agreement (including if such failure is the result of or caused by an event of force majeure under Section 13.16(a))  [***]; and/or (e) a failure by EMERGENT to maintain all necessary licenses and permits required to be held by EMERGENT for the cGMP manufacturing of the Products and performance of the Services, then within [***] after the end of the calendar year in question, EMERGENT shall provide CUSTOMER with written notice of the shortfall payment. [***]

 

 

 

ARTICLE VII

DELIVERIES, INSPECTION, & ACCEPTANCE

 

7.1Delivery.  EMERGENT and CUSTOMER will mutually agree in writing, via the Statement of Schedule, [***],  for each Product when the Parties have sufficient data to reasonably determine such dates, but in any event, for commercial Product, [***]  Product shall be delivered [***]  EMERGENT shall provide CUSTOMER with at least five (5) business days advance notice of the anticipated delivery date.  EMERGENT shall deliver the Product or cause the Product to be [***].  Each delivery of the Product shall be accompanied by an EMERGENT Certificate of Analysis for Product, a bill of lading prepared by EMERGENT, a MSDS (“Material Safety Data Sheet”), and any other documents required by the Quality Agreement, Regulatory Standards or Regulatory Authorities within the Territory or reasonably requested by CUSTOMER.  

7.2Risk of Loss & Title.  Title to, ownership of and risk of loss with respect to all Product delivered hereunder shall pass from EMERGENT to CUSTOMER [***].  For clarity, if shipment is delayed upon the request of CUSTOMER, [***]. Title to, ownership of, [***]CUSTOMER-Provided Materials and Customer Dedicated Equipment shall remain at all times vested in CUSTOMER. 

 

13

 

 

 

 

7.3Delivery Loss.  [***]

7.4Damaged or Defective Product.  

7.4.1Inspection and Notification Time Limits. CUSTOMER shall inspect all shipments of Product for proper labeling, packaging and count [***].  CUSTOMER shall notify EMERGENT in writing [***]of any loss of or damage to the Product, including partial loss, damage, or non‐receipt of any separate part of a shipment or of any defective Product (each an “Impairment”). If an Impairment is not immediately evident to CUSTOMER within [***]period set forth above (i.e. a latent defect), such notification by CUSTOMER to EMERGENT shall be made within [***] discovery of such Impairment by CUSTOMER [***].  Notification by CUSTOMER to EMERGENT of an entire non‐shipment shall be made within [***], or within such other period as may be agreed upon in writing between the Parties. 

7.4.2Investigation of Impairment. In any case where CUSTOMER provides EMERGENT with a notice in respect of an Impairment in accordance with Section 7.4.1, CUSTOMER shall provide EMERGENT with a reasonable opportunity to inspect and/or test such Product. In the event that CUSTOMER does not notify EMERGENT of any Impairment within the notification periods set forth in Section 7.4.1 CUSTOMER will be deemed to have accepted the applicable Products.

7.4.3Testing for Compliance with Specifications.  In the event of any dispute as to whether the Product fails to conform to the warranties in Section 8.2 by reason of non-compliance with the Specifications, such Product shall be tested for conformance with the applicable Specifications by an independent testing organization mutually acceptable to both Parties which analysis shall be binding on CUSTOMER and EMERGENT solely for the purpose of determining whether such Product complies with the Specifications.   The non-prevailing Party will pay for the costs associated with the independent testing.  CUSTOMER shall not under any circumstances dispose of any Product claimed by CUSTOMER or determined by independent testing organization to be non-compliant with the applicable Specifications, without EMERGENT’s prior written consent.  All or part of any delivery of Product determined to be non-compliant with the applicable Specifications shall be held by CUSTOMER for disposition by EMERGENT, at EMERGENT’s expense.

7.4.4Replacement of Defective Services. If: (i) any portion of the Product or Services fails to conform to the warranties set forth in Section 8.2 [***] and (iii) CUSTOMER provides the notice required under Section 7.4.1., [***] 

ARTICLE VIII
REPRESENTATIONS & WARRANTIES

8.1Warranties by both Parties. Each Party represents, warrants and covenants that: 

8.1.1it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, to conduct its business as currently conducted and to enter into this Agreement, and to consummate the transactions contemplated by this Agreement;

 

14

 

 

 

 

8.1.2neither the execution, delivery nor performance of this Agreement by such Party violates or conflicts with, or will violate or conflict with, any provision of such Party’s organizational or governing documents or instruments, nor are there any inconsistencies, to the best of such Party’s knowledge, between the terms of this Agreement and any of such Party’s obligations to third parties or under Applicable Law,[***];

8.1.3the execution, delivery and performance of this Agreement has been duly authorized by such Party’s appropriate authorizing authority or other applicable governing body and by any other necessary corporate or other legal actions of such Party, and this Agreement constitutes the valid and binding obligation of such Party, enforceable in accordance with its terms, except as such enforceability may be limited by general principles of equity or bankruptcy, insolvency, reorganization or similar laws affecting the rights of creditors generally;

8.1.4[***]

8.1.5neither it, nor any of its employees or representatives, has or shall have, directly or indirectly, an agreement or arrangement with any official, employee, or representative of any government or government agency, or any political party under which such official, employee, or representative, or political party shall receive anything of value, whether monetary or otherwise, as a result of any actual or contemplated sale of any Product.

8.2Additional Warranties by EMERGENT.  [***]    

8.3Additional Warranties by CUSTOMER.  CUSTOMER warrants that a) [***]it supplies to EMERGENT will comply with the specifications and requirements, including without limitation [***]

8.4[***]

(a)[***]

(b)[***]

(c)  [***]

 

    [***] 

8.5Disclaimer of Warranties.  [***]

ARTICLE IX
INDEMNITIES / LIMITATION ON LIABILITY

 

15

 

 

 

 

9.1Indemnification by EMERGENT.  EMERGENT shall indemnify and defend CUSTOMER, its Affiliates and their respective  directors, officers, employees, and agents, from and against any and all losses, damages, costs and expenses (including without limitation reasonable attorneys’ fees and expenses), arising out of claims by third parties as a result of (a) [***]  

9.2Indemnification by CUSTOMER.  CUSTOMER will indemnify and defend EMERGENT, its Affiliates and their respective directors, officers, employees, and agents, from and against any and all losses, damages, costs and expenses (including without limitation reasonable attorneys’ fees and expenses) arising out of claims by third parties as a result of (a) [***]

9.3Conditions.  

9.3.1Promptly after a Party (the “Indemnified Party”) obtains knowledge of the existence or commencement of any claim or proceeding, such Indemnified Party will notify the other Party (the “Indemnifying Party”) of such claim or proceeding in writing; provided, however, that any failure to give such notice will not waive any rights of the Indemnified Party except to the extent that the rights of the Indemnifying Party are actually prejudiced thereby.  The Indemnifying Party will assume the defense and settlement of such claim or proceeding with counsel reasonably satisfactory to the Indemnified Party at the Indemnifying Party’s sole risk and expense; provided, however, that the Indemnified Party (a) may join in the defense and settlement of such claim or proceeding and employ counsel at its own expense, and (b) will reasonably cooperate with the Indemnifying Party in the defense and settlement of such claim or proceeding.  The Indemnifying Party may not settle any claim or proceeding without the Indemnified Party’s written consent, unless such settlement [***]

9.3.2[***]

(a)[***]

	
 
	
   
	
(b)[***]  

[***].            

9.4Limitation on Liability.  

(a)NOTWITHSTANDING ANY PROVISION IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR IT’S SUCCESSORS OR PERMITTED ASSIGNS, FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, [***], WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, ANY OTHER LEGAL OR EQUITABLE THEORY OR OTHERWISE, EVEN IF ADVISED OR AWARE OF THE POSSIBILITY OF SUCH DAMAGES OR LOSS.  [***]  

(b)IN ADDITION TO THE FOREGOING AND NOTWITHSTANDING ANY PROVISION IN THIS AGREEMENT TO THE CONTRARY:

 

16

 

 

 

 

(i) [***]

(II)  [***]

(iiI) [***]

(iV) [***] (b) [***]

ARTICLE X
CONFIDENTIALITY AND INTELLECTUAL PROPERTY

10.1Confidentiality.  During the term of this Agreement and for a period of [***] following termination of this Agreement, the Receiving Party agrees not to use the Confidential Information disclosed to it by the Disclosing Party for any purpose except to carry out its obligations hereunder.  The Receiving Party will not disclose such Confidential Information to third parties or to the directors, officers, employees, auditors or financial or legal advisers of the Receiving Party or those of its Affiliates (“Representatives”), except to those Representatives who have a need to know such Confidential Information solely for the purposes of carrying out the Receiving Party’s obligations hereunder and only to the extent necessary for such purposes.  The Receiving Party agrees that it will take all reasonable steps to protect the secrecy of and avoid disclosure or misuse of the Confidential Information of the Disclosing Party in order to prevent it from falling into the public domain or the possession of unauthorized persons, including, without limitation, those steps that the Receiving Party takes to protect the confidentiality of its own confidential information which steps shall be no less than those required to satisfy a reasonable standard of care.  The Receiving Party agrees to notify the Disclosing Party in writing of any misuse or misappropriation of such Confidential Information of the Disclosing Party of which the Receiving Party becomes aware and to cooperate with the Disclosing Party in every reasonable way to help the Disclosing Party regain 

 

17

 

 

 

 

possession of the Confidential Information and prevent its future unauthorized use.

10.2Exception to Nondisclosure Obligation.  The Receiving Party may disclose Confidential Information as required by law, government or judicial order, or stock exchange listing standard, provided the Receiving Party gives the Disclosing Party prompt notice of such requirement so that the Disclosing Party may seek an appropriate protective order and complies with any such protective order (or equivalent) imposed on such disclosure.  If, in the absence of a protective order, the Receiving Party is nonetheless, in the opinion of its outside counsel, required by law, government or judicial order, or stock exchange listing standard, to disclose any Confidential Information, disclosure may be made only as to that portion of the Confidential Information which the Receiving Party is advised in writing by outside counsel as is legally required to be disclosed.  The Receiving Party will exercise its best efforts to obtain assurance that confidential treatment will be accorded any Confidential Information which it is legally required to disclose.

10.3Publicity.  Neither Party will, without the prior consent of the other Party, use the name of the other Party or any of its Representatives in any publicity, news release or advertising relating to this Agreement or the subject matter hereof, disclose to any other person the fact that Confidential Information of the other Party has been disclosed under this Agreement, or any of the terms, conditions, status or other facts with respect this Agreement, except as required by law or stock exchange listing standard and then only with prior notice as soon as possible to the other Party.

10.4Return of Materials.  Upon expiration or termination of this Agreement, or at any time upon request of the Disclosing Party, any Confidential Information which has been furnished by the Disclosing Party to the Receiving Party will, upon the request of the Disclosing Party, be promptly destroyed, except for documentation which must be retained by the Receiving Party to comply with laws or regulations, for archival purposes, and to otherwise prove compliance with the terms of this Agreement.  Upon request, the Receiving Party shall provide the Disclosing Party confirmation of destruction under this Section 10.4.   

10.5No Rights Granted.  All Confidential Information is and shall remain the property of the Disclosing Party.  By disclosing Confidential Information to the Receiving Party, the Disclosing Party does not grant any express or implied right or license to the Receiving Party to or under the Disclosing Party’s patents, copyrights, trademarks, trade secret information or other intellectual property, except as set forth in Section 10.8 and Section 10.10.

10.6Rights and Remedies.  Each Party agrees that monetary damages may not be a sufficient remedy for unauthorized disclosure or use of Confidential Information and thus, in addition to any other rights or remedies that may be available to it, the Disclosing Party shall be entitled to such injunctive or equitable relief that may be deemed proper by a court of competent jurisdiction.

10.7Respective Intellectual Property.  Each Party [***].  Subject to Sections 10.8 and 10.10, neither Party shall be entitled to use the other Party’s Intellectual Property for any purpose or in any manner other than as set forth in this Agreement and the Exhibits attached hereto.

10.8License.  During the term of this Agreement, CUSTOMER grants to EMERGENT a non‐exclusive and royalty-free license for EMERGENT to use CUSTOMER’s Background 

 

18

 

 

 

 

Customer IP, and Customer Arising IP, solely for the performance of the Services by EMERGENT as contemplated under this Agreement and to comply with its obligations under the terms and conditions of this Agreement and the Exhibits attached hereto.

10.9Arising Inventions Ownership.   

10.9.1Arising Inventions that constitute improvements or enhancements to or derivatives [***] (“Customer Arising IP”). EMERGENT shall promptly disclose any such Customer Arising IP and assign to CUSTOMER, without the payment of any additional compensation, EMERGENT’s entire right, title and interest in and to all Customer Arising IP. 

10.9.2Except to the extent owned by CUSTOMER pursuant to Section 10.9.1 hereof, all Arising Inventions that: (i) constitute improvements to or derivatives of [***] (such inventions “Emergent Arising IP”). CUSTOMER shall promptly disclose any such Emergent Arising IP and assign to EMERGENT, [***], CUSTOMER’s entire right, title and interest in and to all EMERGENT Arising IP.   

10.9.3Arising Inventions that are not otherwise owned by either CUSTOMER OR EMERGENT pursuant to Sections 10.9.1 or 10.9.2 respectively shall be owned by CUSTOMER.

10.10 License to Emergent Arising IP.  The aforementioned notwithstanding, EMERGENT hereby grants to CUSTOMER a [***]to use Emergent Arising IP solely to the extent useful to exploit the Products and related manufacturing processes thereof. [***]Notwithstanding the foregoing, nothing in this Agreement shall be construed as CUSTOMER granting, transferring or conveying any license to EMERGENT to exploit (including inter alia, develop, use or commercialize)  Background Customer IP or Customer Arising IP other than as solely required to perform the Services as contemplated in this Agreement, pursuant to the limited license in Section 10.8.  

10.11Right to File for Protection.  Each Party shall be responsible for the preparation, prosecution (including, without limitation, any interferences, reissue proceedings, and reexaminations) and maintenance of its own intellectual property pursuant to Sections 10.7 and 10.9 at its sole cost and expense. Each Party agrees to cooperate so far as reasonably necessary, upon request of the other Party and at the requesting Party’s expense, to assist or enable the requesting Party to obtain or maintain any intellectual property under this Section 10.11 that belongs to such Party. 

ARTICLE XI
TERM AND TERMINATION

11.1Term.  Unless terminated in accordance with the provisions of Section 11.2, the term of this Agreement shall commence on the Effective Date and continue for a period of [***] (the “Initial Term”).  The Initial Term of this Agreement [***].  The Initial Term and all Renewal Terms shall be referred to herein as the “Term”.

11.2Termination.   This Agreement may be terminated:

 

19

 

 

 

 

11.2.1by either Party immediately, in the event of an Insolvency/Bankruptcy Event with respect to the other Party; 

11.2.2 by EMERGENT immediately, [***], upon written notice to CUSTOMER if CUSTOMER fails to pay EMERGENT in full any undisputed amount due and payable in connection with this Agreement within [***]; 

11.2.3by either Party [***], if the other Party has materially breached this Agreement and the breaching Party fails to cure such breach (a) within [***]after receipt of written notice thereof or (b) if such breach cannot be cured within such [***] period, within such period of time as is reasonable to cure such breach, so long as the breaching Party is diligently making efforts to cure such breach, but in no event more than [***] after receiving notice of such breach from the other Party; or

11.2.4by either Party, at any time after the [***]the Initial Term, on sixty (60) months written notice of termination to the other Party.

11.2.5by CUSTOMER pursuant to Section 13.6.2(b)(i) during the Term.  For clarity, such termination right may only be exercised [***] 

11.2.6by CUSTOMER pursuant to and in accordance with Sections 13.16(d) or (e).

11.3Notwithstanding the above, in no event shall notice or intention to terminate be deemed to waive any rights to damages or any other remedy which the Party giving notice of failure to pay or breach under Sections 11.2.2 or 11.2.3 may have as a consequence of such failure or breach.  

11.4Obligations and Duties Upon Termination. 

11.4.1Release from Duties. If this Agreement expires or is terminated, both Parties shall be released from all obligations and duties imposed or assumed hereunder to the extent so terminated, except as expressly provided to the contrary in this Agreement.  

11.4.2Treatment of Confidential Information. Upon termination, both Parties shall cease any further use of the Confidential Information disclosed to it by the other Party, and such Confidential Information will be returned or destroyed in accordance with Section 10.4.   

11.4.3Outstanding Payment Obligations. Termination of this Agreement, for whatever reason, shall not affect the obligation of either Party to make any payments for which it is liable and which have become due and payable prior to or upon such termination.  Upon any termination of this Agreement, CUSTOMER shall be financially responsible for commitments made under this Agreement and [***] 

ARTICLE XII
INSURANCE

12.1Product Liability Insurance.  CUSTOMER and EMERGENT each agree at its own expense and for the duration of this Agreement, to maintain product liability insurance coverage of at least [***].  CUSTOMER and EMERGENT will provide a Certificate of Insurance to the other upon request, and such coverage will remain in effect [***]  

 

20

 

 

 

 

12.2Insurance; Liability to Third Persons.  EMERGENT and CUSTOMER each shall, at their own expense, obtain and thereafter maintain comprehensive general liability (bodily injury and property damage) insurance, with respect to their respective obligations under this Agreement. Each Party shall immediately give the other or its representative notice of any suit or action filed, or prompt notice of any claim made, against them arising out of the performance of this Agreement.

ARTICLE XIII
MISCELLANEOUS

13.1Non-Exclusive Rights. CUSTOMER and its Affiliates may at any time contract with other parties for the manufacture of the Product and EMERGENT shall not have any exclusive rights to be the sole manufacturer of the Product.     

13.2Independent Contractor.  EMERGENT shall at all times during the term of this Agreement be an independent contractor, maintaining sole and exclusive control over its personnel and operation.  It is understood that all work performed by EMERGENT under this Agreement, and the detailed manner and method of doing the same, shall be under the control of EMERGENT, CUSTOMER being interested only in the results obtained.  At no time will either EMERGENT or CUSTOMER hold itself out to be the agent, employee, lessee, sub-lessee, partner or joint venturer of the other, and it is further understood and agreed between the Parties that the full and exclusive relationship between them is that of an independent contractor.  Nothing in this Agreement shall be construed to create any agency, employment, partnership, joint venture or similar relationship between the Parties other than that of an independent contractor.  Neither Party shall have any right or authority whatsoever to incur any liability or obligation (express or implied) or otherwise act in any manner in the name or on the behalf of the other, or to make any promise, warranty or representation binding on the other.  EMERGENT and CUSTOMER agree not to use the name of or refer to, the other Party without prior written permission, in any public statements, whether oral or written, related to this Agreement except as required by law or stock exchange listing standards and then only with prior notice as soon as possible to the other Party.

13.3Product Complaints.  CUSTOMER or its Affiliates shall be responsible for the handling of all Product complaints, including those associated with Manufacturing and packaging.  EMERGENT shall reasonably cooperate in the investigation by CUSTOMER of Product complaints involving Manufacturing and packaging by EMERGENT as provided for in the Quality Agreement.

13.4Governing Law.  This Agreement shall be construed, and legal relations between the Parties hereto shall be determined, in accordance with the laws [***] applicable to contracts solely executed and wholly to be performed within [***]without giving effect to the principles of conflicts of laws.

13.5Assignment.  This Agreement shall be binding upon the successors and assigns of the Parties.  [***] Any purported assignment without a required consent shall be void.  No assignment shall relieve any Party of responsibility for the performance of any obligation, which accrued prior to the effective date of such assignment.

	
 
	
13.6
	
Restrictions.

13.6.1[***] 

 

21

 

 

 

 

13.6.2[***]

(a) [***] (b)[***]

 

	
 
	
(i)
	
[***]   

	
 
	
(ii)
	
[***]

	
 
	
 
	
(c)[***]

(d)[***]

(e)[***]

13.7Disputes.  Except with respect to disputes arising under Section 7.4 (which shall be resolved pursuant to Section 7.4.3, and disputes relating to pricing and/or payments, which shall be resolved pursuant to Sections 13.8 and 13.9), in the event of a dispute between the Parties: 

(a)the Parties shall first shall attempt in good faith to find an amicable settlement to such dispute promptly by negotiations between representatives of CUSTOMER and EMERGENT who have authority to settle the controversy; 

	
 
	
(b)
	
 If, within [***]following the commencement of the discussions under Section 13.7(a), the Parties cannot settle such dispute, such dispute shall be solely and finally settled by arbitration, which shall be conducted in [***].  The Parties hereby agree that the award of the Arbitrator Panel shall be final and subject to no judicial review. Notwithstanding the foregoing, the Parties shall have the right to seek injunctive relief before the competent courts. The Arbitrator Panel shall conduct the proceedings pursuant to the Arbitration Rules of the Canadian Arbitration Association.  All substantive questions of law shall be determined under the laws of [***] (without regard to the principles of conflict of laws of [***]).  Judgment on the award of the Arbitrator Panel may be entered into any court having jurisdiction over the Party against which enforcement of the award is being sought, and the Parties hereby irrevocably consent to the jurisdiction of any such court for the purpose of enforcing any such award. [***]

13.8Expedited [***]

13.8.1The Expert shall be chosen in accordance with Section 13.9.

13.8.2[***]

13.8.3[***]

 

22

 

 

 

 

13.9Expert Selection – Any matter which is to be determined by an Expert pursuant to Section 13.8, will be referred to a person suitably qualified to determine that matter who will be nominated by the Party seeking resolution of such dispute and approved by the other Party, such approval not to be unreasonably withheld, conditioned or delayed.  The Expert will act as an expert and not as an arbitrator and his terms of appointment will include:

13.9.1a requirement on the Expert to act fairly;

13.9.2unless otherwise agreed by the Parties, a requirement on the Expert to hold adequate professional indemnity insurance both then and for at least the period of statutory limitation following the date of his determination;

13.9.3confidentiality obligations reasonably acceptable to the Parties; and

13.9.4a commitment by the Parties to supply to the Expert all such assistance, documents and information as he may reasonably require for the purpose of his determination.

13.10[***]  

13.11 Notice.  All notices or communication required or permitted to be given by either Party hereunder shall be deemed sufficiently given if mailed by registered mail or certified mail or sent by overnight courier, such as Federal Express, to the other Party at its respective address set forth below or to such other address as one Party shall give written notice of to the other from time to time hereunder.  Mailed notices shall be deemed to be received on the third business day following the date of mailing.  Notices sent by overnight courier shall be deemed received the following business day.

If to CUSTOMER:

ProMetic Life Sciences Inc.

440 Armand-Frappier Blvd.

Suite 300

Laval, Quebec

H7V 4B4

Fax: (450) 781-4477

Attn.: President

 

WITH A COPY TO:

 

PROMETIC LIFE SCIENCES INC.

440, Boulevard Armand-Frappier,

Suite 300, Laval, Québec

H7V 4B4

Fax:  (450) 781-4477

Attention:  Legal Department

 

 

23

 

 

 

 

If to EMERGENT:

Emergent BioSolutions

400 Professional Drive

Suite 400

Gaithersburg, MD 20879

Attn: [***]

 

WITH A COPY TO:

 

Emergent  BioSolutions

155 Innovation Drive

Winnipeg, Manitoba, 

Canada R3T 5Y3

Attn: Legal Affairs 

 

13.12Compliance with All Laws.  In all activities undertaken pursuant to this Agreement, both EMERGENT and CUSTOMER covenant and agree that [***]comply with such Applicable Laws and Regulatory Standards, as may be in effect at the time of performance and all valid rules, regulations and orders thereof regulating such activities.  For clarity [***]    

13.13No Waivers; Severability.  No waiver of any breach of this Agreement shall constitute a waiver of any other breach of the same or other provision of this Agreement, and no waiver shall be effective unless made in writing.  Any provision hereof prohibited by or unenforceable under any applicable law of any jurisdiction shall as to such jurisdiction be deemed ineffective and deleted herefrom without affecting any other provision of this Agreement.  It is the desire of the Parties hereto that this Agreement be enforced to the maximum extent permitted by law, and should any provision contained herein be held by any governmental agency or court of competent jurisdiction to be void, illegal or unenforceable, the Parties shall negotiate in good faith for a substitute term or provision which carries out the original intent of the Parties.  If the Parties cannot reach agreement upon such a substitute term or provision within [***] original term or provision is held void, illegal or unenforceable, then the matter shall be settled by binding arbitration in accordance with Section 13.7.

13.14Entire Agreement; Amendment.   CUSTOMER and EMERGENT acknowledge that they have read this entire Agreement and that this Agreement, including the attached Exhibits, constitutes the entire understanding and contract between the Parties hereto and supersedes any and all prior or contemporaneous oral or written communications with respect to the subject matter hereof, all of which communications are merged herein.  It is expressly understood and agreed that this Agreement shall not be modified, amended or in any way altered except by an instrument in writing signed by both of the Parties hereto.

13.15Delays or Omissions.  Except as expressly provided herein, no delay or omission to exercise any right, power or remedy accruing to any Party hereto, shall impair any such right, power or remedy to such Party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or in any similar breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring.  Any waiver, permit, consent or 

 

24

 

 

 

 

approval of any kind or character on the part of any Party of any breach or default under this Agreement, or any waiver on the part of any Party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing.  

13.16Force Majeure. (a) If EMERGENT fails to fulfill its obligations hereunder [***], in whole or in part, and  such failure is due to an act of God, or any other circumstance beyond its reasonable control, including but not limited to equipment failure, fire, flood, civil commotion, riot, war (declared and undeclared), revolution, action by government (including but not limited to delays in obtaining governmental approvals or embargoes), supplier delays, and breakdown or general unavailability of materials (including Plasma) or transportation facilities, then said failure  shall be excused for the duration of such event and for such a time thereafter as is reasonable to enable Emergent to resume performance under this Agreement, subject to CUSTOMER’s right to terminate this Agreement under subsection (e) below. 

(b) If CUSTOMER fails to fulfill its obligations hereunder [***], in whole or in part, and such failure is due to an act of God, or any other circumstance beyond its reasonable control, including but not limited to equipment failure, fire, flood, civil commotion, riot, war (declared and undeclared), revolution, action by government (including but not limited to delays in obtaining governmental approvals or embargoes), supplier delays, an event of force majeure suffered by its [***]suppliers or general unavailability of materials [***], or transportation facilities, then said failure shall be excused for the duration of such event and for such a time thereafter as is reasonable to enable CUSTOMER to resume performance under this Agreement, subject to CUSTOMER’s right to terminate under subsection (e) below. [***]  

(c) The non-performing Party shall use all commercially reasonable efforts to resume performance of its obligations under this Agreement and shall notify the other Party in writing as soon as practicable, of its detailed remedial plan and timelines to resume the performance under this Agreement. 

(d)  If (i) EMERGENT fails to perform any of its obligations under this Agreement by reason of force majeure as defined in subsection (a) above, (ii) such non-performance is not the result of or caused by a failure of the CUSTOMER to perform it obligations under subsection (b) above, and (iii) such non-performance continues for a period of [***]of the event of force majeure, CUSTOMER may[***], terminate this Agreement by providing [***]prior written notice to that effect to EMERGENT.    

(e) If (i) CUSTOMER fails to perform any of its obligations under this Agreement by reason of force majeure as defined in subsection (b) above and (ii) such non-performance continues for a period of [***]and such non-performance prevented EMERGENT from performing [***], CUSTOMER may, [***], terminate this Agreement by providing [***]  

(f)  In the event of a termination under subsection (d) or (e) above, both Parties’ respective rights and obligations under this Agreement shall terminate, except for any amounts previously due and owing by one Party to the other as of the effective date of termination and except as otherwise expressly provided to the contrary in Section 13.17 of this Agreement. 

13.17Survival.  All representations, warranties, covenants and agreements made herein and which by their express terms or by implication are to be performed after the execution and/or 

 

25

 

 

 

 

termination hereof, or are prospective in nature, shall survive such execution and/or termination, as the case may be, including without limitation Section 2.4 (Import and Export), Section 4.9 (Removal of Customer Dedicated Equipment), Section 5.2 (General Labeling), Section 7.2 (Risk of Loss and Title), Section 7.4 (Damaged or Defective Product), ARTICLE VIII (Representations and Warranties), ARTICLE IX (Indemnities/Limitation on Liability), ARTICLE X (Confidentiality and Intellectual Property), Section 11.3, Section 11.4 (Obligations and Duties Upon Termination), ARTICLE XII (Insurance), and ARTICLE XIII (Miscellaneous). 

13.18No Third Party Beneficiaries.  Nothing in this Agreement shall be construed as giving any person, firm, corporation or other entity, other than the Parties hereto and their successors and permitted assigns, any right, remedy or claim under or in respect of this Agreement or any provision hereof.

13.19Headings; Exhibits.  Section headings are for convenient reference and not a part of this Agreement.  All Exhibits are incorporated herein by this reference.

13.20Counterparts.  This Agreement may be executed in counterparts and by facsimile or electronic mail, whereby each counterpart shall be deemed an original and all of which when taken together shall be deemed but one instrument.

13.21Currency.  Unless otherwise indicated, all monetary amounts are expressed in this Agreement in the lawful currency of [***]

13.22Singular Terms.  Except as otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa.

IN WITNESS WHEREOF, this Agreement shall take effect as of the date first written above when it has been executed below by the duly authorized representatives of the Parties.

 

 

CANGENE CORPORATION

doing business as Emergent BioSolutions 

 

By:  /s/Barry Labinger

Title:  President

Date:  May 15, 2015

 

PROMETIC LIFE SCIENCES INC.

 

By:  /s/ Pierre Laurin

Title:  President and CEO

Date:  May 15, 2015

 

26

 

 

 

 

LIST OF EXHIBITS:

 

Exhibit A.[***]Exhibit B.Plasma Specifications

Exhibit C.Products

Exhibit D.Quality Agreement

Exhibit E:Customer Dedicated Equipment

Exhibit F:[***]Exhibit G: [***]

Exhibit H:[***]

Exhibit I:[***]

Exhibit W[***]Exhibit X Form of Statement of Work

Exhibit YForm of Statement of Schedule

 

 

 

 

 

 

 

27

 

 

 

 

EXHIBIT A

				
	
[***]

	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

 

 

28

 

 

 

 

EXHIBIT B

Plasma Specifications

 

		
	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
•[***]
	
[***]

	
•[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
o[***]

	
[***]
	
o[***]

	
[***]
	
•[***]

 

 

29

 

 

 

 

EXHIBIT C

Products 

 

[***] 

 

1.            [***]2.            [***]

3.            [***]

4.            [***]

5.            [***]

6.            [***]7.            [***]8.            [***]

9.            [***]

10.            [***]

11.            [***]

12.            [***]

13.            [***]

14.            [***]

15.            [***]

16.            [***]

17.            [***]

18.            [***]

19.          [***]

 

30

 

 

 

 

EXHIBIT D

Quality Agreement

 

[***]

 

31

 

 

 

 

EXHIBIT E

Customer Dedicated Equipment

 

[***]

 

32

 

 

 

 

EXHIBIT F

[***]

[***]

 

33

 

 

 

 

EXHIBIT G

[***]

[***][***]

 

EXHIBIT H

[***]

 

	
 
	
1.
	
[***]

	
 
	
2.
	
[***]

	
 
	
3.
	
[***]

	
 
	
4.
	
[***]

	
 
	
5.
	
[***]

	
 
	
6.
	
[***]

	
 
	
7.
	
[***]

	
 
	
8.
	
[***]

	
 
	
9.
	
[***]

	
 
	
10.
	
[***]

 

 

34

 

 

 

 

EXHIBIT I

[***]

 

	
 
	
1.
	
[***]

	
 
	
2.
	
[***]

	
 
	
3.
	
[***]

	
 
	
4.
	
[***]

	
 
	
5.
	
[***]

	
 
	
6.
	
[***]

	
 
	
7.
	
[***]

	
 
	
8.
	
[***]

	
 
	
9.
	
[***]

 

35

 

 

 

 

EXHIBIT W

[***]

[***]

[***][***][***][***][***][***][***][***][***][***][***]

[***]

 

36

 

 

 

 

EXHIBIT X

Form of Statement of Work

 

[***]

 

[***]1. [***] 

A. [***]

B. [***]

2. [***]

 

3. [***] 

	
 
	
➢
	
[***]

	
 
	
➢
	
[***]

	
 
	
➢
	
[***]

	
 
	
➢
	
[***]

 

4. [***]

 

5. [***]

	
 
	
➢
	
[***]  

	
 
	
1.
	
[***]

	
 
	
1.
	
[***]

	
 
	
2.
	
[***]

	
 
	
3.
	
A[***]

 

	
 
	
➢
	
[***]

 

6. [***]

 

7. [***]

	
 
	
➢
	
[***]

	
 
	
➢
	

 

	
 
	
➢
	
[***]

	
 
	
➢
	
[***]

 

8. [***][***]

[***][***]

[***]

[***]

 

 

37

 

 

 

 

[***]  [***]

[***][***]

[***]

[***]

IN WITNESS WHEREOF, Emergent and Prometic have executed this Statement of Work to be effective as of the Effective Date.

 

		
	
Cangene Corporation

d/b/a Emergent BioSolutions

 

By:  (form only—do not sign)_____________

 

Name: _______________________________

 

Title:   _______________________________

 

Date: ________________________________

 
	
ProMetic Life Sciences, Inc.

 

By:  (form only—do not sign)_____________

 

Name: _______________________________

 

Title:   _______________________________

 

Date: ________________________________

 

 

 

 

 

 

38

 

 

 

 

EXHIBIT Y

Form of Statement of Schedule

 

[***]

 

[***]

1. [***]

[***]

2. [***]: 

 

	
 
	
➢
	
[***]

 

 

3. [***] 

 

4. [***][***][***]

[***][***]

[***][***]

 

[***]  [***]

[***][***][***]

 

IN WITNESS WHEREOF, Emergent and Prometic have executed this Statement of Schedule to be effective as of the Effective Date.

 

		
	
Cangene Corporation

d/b/a Emergent BioSolutions

 

By:  (form only—do not sign)_____________

 

Name: _______________________________

 

Title:   _______________________________

 

Date: ________________________________

 
	
ProMetic Life Sciences, Inc.

 

 

By:  (form only—do not sign)_____________

 

Name: _______________________________

 

Title:   _______________________________

 

Date: ________________________________

 

 

 

 

 

 

39lmnl-ex426_362.htm

 

Exhibit 4.26

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE LIMINAL BIOSCIENCES INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO LIMINAL BIOSCIENCES INC. IF PUBLICLY DISCLOSED.

 

ROYALTY STREAM PURCHASE AGREEMENT

This Royalty Stream Purchase Agreement (the “Agreement”) is entered into and effective as of the 30th day of April 2018 (the “Effective Date”), by and between Prometic Life Sciences Inc., Prometic Pharma SMT Limited, Prometic Biosciences Inc. and each of their Affiliates that at any time holds an interest in the Patents or licenses any rights thereunder and becomes a party hereto as provided in Section 5(a), which entities shall be set forth on Schedule “C” hereto which schedule shall be updated as applicable from time to time (collectively referred to as “Prometic”), on the first hand, and Structured Alpha LP (“SALP” or “Buyer”), on the second hand. 

WHEREAS Prometic and SALP have entered into a certain loan agreement dated November 30, 2017 (the “Loan Agreement”); whereby SALP has agreed to make available to Prometic and its Affiliates (as defined hereinafter), a non-revolving, delayed-draw term loan in two (2) tranches, each of which may be advanced pursuant to multiple advances upon satisfaction of the conditions specified in such Loan Agreement; 

WHEREAS concurrently with the signature of this Agreement, SALP, Prometic and its Affiliates entered into an amendment to the Loan Agreement (the “Amendment”), to amend the conditions precedent to the drawing of up to four (4) advances of US$10,000,000 each, under the second (2nd) tranche of the credit facility available under such Loan Agreement (each advance under the second (2nd) tranche hereinafter individually referred to as an “Advance” and collectively hereinafter referred to as “Advances”);

WHEREAS it is a condition to the consummation of the Amendment that SALP and Prometic enter into this Agreement pursuant to which Prometic agrees to sell, and SALP agrees to purchase, a stream of royalty payments based on the Net Sales, Joint Venture Revenues and Licensing Revenues (as defined hereinafter) associated with the Patents (as defined hereinafter); the whole subject to the terms and conditions of this Agreement. 

NOW THEREFORE THIS AGREEMENT WITNESSES that, in consideration of the covenants and agreements herein contained, and other valuable consideration, the receipt of which is hereby acknowledged, the parties hereto agree as follows:

	
1.
	
DEFINITIONS

In addition to capitalized terms defined elsewhere in this Agreement, the following capitalized terms shall have the meanings set forth below:

(a)“Affiliate” means with respect to any Party, any person directly or indirectly controlling, controlled by or under common control with such Party. For purposes of this definition, a person shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting 

Page 1

 

 

securities of another entity (or other comparable ownership interest for an entity other than a corporation) or if it has direct or indirect management control of the other entity.

(b)“Buy-Out Fee” shall have the meaning ascribed thereto in Section 2(d).

(c)“Equity Interest” means a share of capital stock, a partnership interest, a membership interest or a quota in a limited liability company or similar entity, a beneficial interest in a trust, and any warrants, options or other right to acquire any such share, partnership interest, membership interest, quota, beneficial interest or any other equity interest in any Person.

(d)“Joint Venture Company” means a Person that is a counterparty to a Licensing Agreement or the recipient of a sublicense of any rights thereunder or a transferee of any Patents, and in respect of which Prometic or a Prometic Affiliate has an Equity Interest (other than a directly or indirectly wholly-owned Affiliate of: (i) Prometic Life Sciences Inc., or (ii) any entity that is the successor to substantially all of the business of Prometic Life Sciences Inc. and its subsidiaries as of the Effective Date hereof). 

(e)“Joint Venture Revenues” means [***].

(f)“Licensing Agreement” means a licensing agreement or a sub-licensing agreement entered into by Prometic or by a Prometic Affiliate, on the first hand, and a third party or Joint Venture Company, on the second hand, granting exclusive or non-exclusive rights to use the Patents (or rights under the Patents) to develop, make or sell, or to cause a third party to develop, make or sell, the Product in the Territory.

(g)“Licensing Revenues” means, without duplication, [***].

(h)“Minimum Amount” means, in respect of any Quarter, any positive amount obtained by subtracting (i) the percentage of Net Sales, Licensing Revenues and Joint Venture Revenues in respect of such Quarter payable by any Prometic Party to SALP pursuant to Section 2(a), from (ii) [***].

(i)“Minimum Payment” shall have the meaning ascribed thereto in the definition of “Royalty Entitlement”.

(j)“Net Sales” means, for any specific period, any gross amounts received by Prometic or a Prometic Affiliate (other than a Joint Venture Company), or by an agent acting on behalf of Prometic or a Prometic Affiliate (other than a Joint Venture Company), from a third party on all Products sold or transferred, less the following items to the extent such items are actually incurred and separately itemized: (i) customary cash, trade and quantity discounts or rebates actually allowed and taken which effectively reduce the invoiced price; (ii) sales, value added, excise or other taxes imposed upon and paid directly with respect to such sales (excluding taxes based on income); (iii) costs with respect to transportation packaging, freight, transportation, insurance and duties incurred by Prometic and/or its Affiliates in shipping the Products to a third party and included in the amount invoiced to such third party; and (iv) allowances, credits, chargebacks and refunds granted on account of rejection, recalls, return or price reduction actually allowed and taken and which effectively reduce the invoiced price. Sales between or among Prometic and any Prometic Affiliate for purposes of resale shall be excluded from the computation of Net Sales. Any Products used by Prometic or any Prometic Affiliate as end users, or sold or otherwise transferred by any of them to a third party other than in an arms-length transaction shall be deemed to be invoiced for the fair market value of the Product, provided that the sale or supply of Product as commercial samples, for use in research or clinical studies or for patient assistance programs, named patient sales, or compassionate use programs or the like, shall be excluded from the calculation of Net Sales provided no monetary consideration above the cost to supply such Product is received for such transfer or disposition. Net Sales shall also include any monies awarded to Prometic or any Prometic Affiliate as a result of any action or settlement filed or made in connection with the infringement or threatened infringement of the Patents or other exclusivity rights 

 

Page 2

 

 

of Prometic or any Prometic Affiliate in respect of Products by a third party (after such monies have been applied to reimburse any parties for their costs incurred in connection with such action or settlement). For greater certainty, no amount that is taken into consideration in the determination of the Net Sales shall be included in the calculation of Joint Venture Revenues or Licensing Revenues.

(k)“Party” means each of SALP and Prometic and “Parties” means SALP and Prometic.

(l)“Patents” means any and all current patents and patent applications (as well as any patent applications (and patents issued from such patent applications) filed in [***] following the Effective Date) relating to Prometic’s small molecule therapeutics designated as [***]; as initially listed in Schedule “A” attached hereto; and any patents issued from such applications and any divisions, continuations, continuations-in-part, re-issues, re-examinations, renewals, patents of importation, patents of addition, extensions and foreign counterparts to any of the foregoing (including any patent term extension under 35 USC §156, any Supplementary Protection Certificate (within the meaning of such term under Council Regulation (EU) No. 1768/92) or any other similar statutory protection in relation to a product).

(m)“Person” means an individual, corporation, partnership, limited liability company, association, trust or other entity or organization, but not including a government or political subdivision or any agency or instrumentality of such government or political subdivision.

(n)“Product” means a drug substance (i) covered by one or more Valid Claim within the Patents that is approved by the FDA or any other Regulatory Authority for commercial sale or (ii) that was previously covered by such a Valid Claim and is covered by an exclusivity period pursuant to protection by “Orphan Drug” status (within the meaning of such term under the U.S. Orphan Drug Act) and/or any type of data exclusivity or data protection or any similar statutory or regulatory protection in the relevant country that provides exclusivity or any other protection or advantage vis-à-vis competitors in respect of a product).

(o)“Purchase Price” shall have the meaning ascribed thereto in Section 2(a).

(p)“Quarter” means each calendar quarter that begins on the first day of each January, April, July and October during the Term; provided, however, that the first Quarter will commence on the Effective Date and end on the day preceding the first day of the next Quarter.

(q)“Regulatory Approval” means the approval to market a Product in a country for therapeutic use, in the case of the United States by the FDA and, in the case of any other country, by the Regulatory Authority of competent jurisdiction in that country.

(r)“Regulatory Authority” means any governmental authority in any country responsible for regulatory approvals and post-marketing surveillance of any Product. 

(s)“Royalty Entitlement” means, for any Quarter, the greater of (i) a minimum payment of [***] in respect of such Quarter (the “Minimum Payment”), and (ii) the percentage of Net Sales, Licensing Revenues and Joint Venture Revenues in respect of such Quarter payable by any Prometic Party to SALP pursuant to Section 2(a), less any set-off of any previously paid Minimum Amount pursuant to Section 6(b).

(t)“Sales Tax” shall have the meaning ascribed thereto in Section 9(a).

(u)“SALP Interest” shall have the meaning ascribed thereto in Section 2(d).

(v)“Territory” means the world.

 

Page 3

 

 

(w)“Term” shall have the meaning ascribed thereto in Section 8(a).

(x)“Valid Claim” means (a) any claim of an issued and unexpired Patent that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable, or (b) a claim of a pending patent application in the Patents, which claim has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application.

	
2.
	
PURCHASE AND SALE OF THE ROYALTY ENTITLEMENT

(a)Purchase and Sale of Royalty Entitlement. Upon the terms and subject to the conditions of this Agreement, and provided that SALP has paid the first Milestone Fee corresponding to the first milestone set forth below, Prometic agrees to sell to SALP the Royalty Entitlement described as follows (subject to the Minimum Payment described in the definition of “Royalty Entitlement”), and SALP agrees to purchase from Prometic the Royalty Entitlement and to pay to Prometic the applicable portion of the milestone fees (each, a “Milestone Fee”, and collectively, the “Purchase Price”) set forth below upon the achievement of the corresponding milestones, on the milestone payment dates set forth below.

				
	
 

Milestones
	
Royalty Entitlement

(cumulative percentages)

 
	
 

Milestone Fee
	
Milestone

Payment Date

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]
	
[***]

 

As a condition in favour of SALP to the payment of each subsequent Milestone Fee payment (after the first Milestone Fee payable in connection with the execution of this Agreement), the representations and warranties set forth in Section 3 hereof (other than Section 3(h)) shall be true and correct as if such representations and warranties had been made as of the applicable milestone payment date, and all Schedules to this Agreement shall be updated as required pursuant to the terms hereof, in each case as of the applicable milestone payment date, and a senior officer of Prometic Life Sciences Inc. shall execute and deliver a certificate confirming the satisfaction of this condition to SALP on the applicable milestone payment date.

(b)Payment. Each Milestone Fee (other than the first Milestone Fee corresponding to the first milestone set forth in Section 2(a) which is due and payable by SALP to Prometic upon execution of this Agreement) shall be due and payable by SALP to Prometic not later than ten (10) days following the respective milestone payment date. Any Milestone Fee may be paid by SALP by way of setting off and extinguishing a corresponding nominal amount of interest under the Loan Agreement (as amended by the Amendment) or, at the election of SALP, any other liability or other obligation arising under the Loan Agreement (as amended by the Amendment). SALP may effect any such set off and extinguishment by giving five (5) business days prior written notice (a “Set-Off Notice”) to Prometic specifying (i) the nominal amount owing being set off and extinguished in satisfaction of the Milestone Fee and the description and characterization of such amount, and (ii) the amount 

 

Page 4

 

 

of the Milestone Fee being paid. To the extent that the amount being set off and extinguished is on account of principal, such set off and extinguishment shall constitute an authorized prepayment and the relevant principal amount shall be correspondingly reduced. SALP and Prometic further acknowledge, understand and agree that SALP’s presentation of a Set-Off Notice to Prometic shall constitute a full answer and defence by SALP and its Affiliates against any liability or obligation in respect of the Milestone Fee specified in the related Set-Off Notice and a full answer and defence by Prometic and its Affiliates against any liability or obligation owing to SALP or its Affiliates to the extent of the applicable nominal amount being set off and extinguished as specified in the Set-Off Notice. If payment of a Milestone Fee is effected by means of setting off and extinguishing Canadian dollar-denominated liabilities or obligations, then the Canadian dollar amount of the liabilities and obligations being set off and extinguished shall be deemed to be an amount equal to the Canadian dollar amount of the Milestone Fee being paid, determined by reference to the daily average Canadian-US dollar exchange rate published by the Bank of Canada for the applicable date of payment. The Parties agree, notwithstanding any provision herein to the contrary, that (i) each payment payable by SALP hereunder shall be paid by SALP to Prometic Biosciences Inc., (ii) each payment payable to SALP hereunder shall be paid to SALP by Prometic Biosciences Inc. which payment obligation shall be unconditionally guaranteed by Prometic Life Sciences Inc., (iii) none of Prometic Biosciences Inc. or Prometic Life Sciences Inc. shall at any time be a non-resident of Canada for purposes of the Income Tax Act (Canada), and (iv) none of Prometic Biosciences Inc. and Prometic Life Sciences Inc. may assign or delegate its rights or obligations under this sentence.

(c)No Assumed Obligations. Notwithstanding any provision in this Agreement or any other writing to the contrary, SALP is acquiring only the Royalty Entitlement and is not assuming any liability or obligation of Prometic of whatever nature, whether currently in existence or arising or asserted hereafter. All such liabilities and obligations shall be retained by and remain obligations and liabilities of Prometic. 

(d)Buy-Out Right. The Parties agree that for [***] period commencing on [***], Prometic and/or any Prometic Affiliate shall have the right to purchase from SALP, and SALP shall have the obligation to sell to Prometic and/or any such Prometic Affiliate, all of SALP’s rights, title and interests in this Agreement, including (i) the Royalty Entitlement (including any Royalty Entitlement that would have been payable in the future during the remaining term of this Agreement had the right under this Section 2(d) not been exercised) and (ii) any other amounts due and payable by Prometic and/or any Prometic Affiliate to SALP hereunder arising on or prior to the date of closing of the acquisition of the  SALP Interest by Prometic and/or any Prometic Affiliate, as applicable, pursuant to this Section 2(d) (other than the right to receive the Buy-Out Fee) (the “SALP Interest”) upon payment to SALP of the Buy-Out Fee, which right will be exercisable by Prometic and/or any such Prometic Affiliate upon giving SALP at least a three (3) month prior written notice. The “Buy-Out Fee” shall mean the amount payable by or on behalf of Prometic and/or any Prometic Affiliate to SALP for the SALP Interest, which amount shall be equal to the fair market value of the SALP Interest, determined on a net present value basis, having regarding to the remaining life of the Patents (and any relevant extensions or additional exclusivity periods that may be associated with such Patents or Products sold thereunder) and associated cash flows, all as determined pursuant to a valuation performed by a mutually agreed upon third party, such as an independent investment bank or consultancy firm skilled in the valuation of assets of a similar nature. The parties shall negotiate acting reasonably and in good faith to mutually agree upon a third party to determine the amount of the Buy-Out Fee, but if they are unable to do so within a thirty (30) day period then any party hereto may apply to the Ontario Superior Court of Justice for the purposes of having the court appoint such a third party. The Buy-Out Fee shall be paid concurrently with the closing of the acquisition of the SALP Interest by Prometic and/or a Prometic Affiliate, as applicable, and may be payable, at SALP’s option, in Prometic Life Sciences Inc.’s common shares, cash or a combination thereof, such option to be exercised by SALP at least 10 days prior to the payment of the Buy-Out Fee, and any payment in common shares shall be based on the fair market value thereof, which fair market value shall be deemed to be, if the common shares are listed on the TSX or any other exchange, the volume weighted average price of such common shares on the five trading days immediately prior to SALP’s exercise of its option to receive the Buy-Out Fee in common shares, or any other calculation method mandated by the TSX or such other exchange. Prometic shall use its commercially reasonable efforts to obtain the prior approval of the TSX in 

 

Page 5

 

 

connection with SALP’s option to receive the Buy-Out Fee in common shares at the time of obtaining the initial approval of the TSX of this Agreement. Following the exercise of this Buy-Out Right in accordance with this Section 2(d), SALP shall have no further rights under this Agreement except for the right to receive the Buy-Out Fee, and this Agreement shall terminate and be of no further force and effect, except for those provisions which by their terms or nature are intended to survive the termination of this Agreement.

	
3.
	
REPRESENTATIONS AND WARRANTIES OF PROMETIC

As of the Effective Date, each Prometic Party hereby represents to SALP as follows:

(a)Corporate Existence and Power. Prometic is a corporation duly incorporated, validly existing and in good standing under the laws of its jurisdiction of incorporation and has all corporate powers and all material governmental licenses, authorizations, consents and approvals required to carry on its business as now conducted.

(b)Corporate Authorization. The execution, delivery and performance by Prometic of this Agreement, and the consummation by Prometic of the transactions contemplated hereby are within Prometic’s corporate powers and have been duly authorized by all necessary corporate action on the part of Prometic. This Agreement has been duly executed and delivered by Prometic and constitutes a valid and binding agreement of Prometic, subject to any limitation on enforcement under applicable laws relating to (i) bankruptcy, winding-up, insolvency, arrangement and other laws of general application affecting the enforcement of creditors' rights and (ii) the discretion that a court may exercise in the granting of extraordinary remedies such as specific performance and injunction.

(c)Non-Contravention. The execution, delivery and performance by Prometic of this Agreement does not: (i) contravene or conflict with the corporate charter or bylaws of Prometic; (ii) contravene or conflict with or constitute a material violation of any provision of any law or regulation or the rules of any stock exchange binding upon or applicable to Prometic; (iii) contravene or conflict with or constitute a material violation of any judgment, injunction, order or decree binding upon or applicable to Prometic; (iv) constitute a material default under any agreement or give rise to any right of termination, cancellation or acceleration of any right or obligation of Prometic or to a loss of any material benefit which, in each case, could reasonably be expected to have an adverse effect on the Patents, the Products, Prometic or Prometic’s ability to pay the Royalty Entitlement as contemplated by this Agreement; or (v) result in the creation or imposition of any Lien (except for any Lien in favor of SALP).

(d)No Undisclosed Material Liabilities. To Prometic’s knowledge, there are no undisclosed material liabilities related to the Royalty Entitlement of any kind whatsoever, whether accrued, contingent, absolute, determined, determinable or otherwise, and Prometic has no knowledge of any existing condition, situation or set of circumstances that could reasonably be expected to result in such a liability.

(e)Litigation. There is no action, suit or proceeding of which Prometic has received notice, pending or, to the knowledge of Prometic, threatened, before any governmental authority or arbitrator, which has or could have a material adverse effect on the Patents, the Products, Prometic or Prometic’s ability to pay the Royalty Entitlement.

(f)Compliance with Laws. To Prometic’s knowledge, Prometic is not in violation of, has not violated, and to the knowledge of Prometic, is not under investigation with respect to and has not been threatened to be charged with or given notice of any violation of, any applicable law, rule, ordinance or regulation, or judgment, order or decree entered by any Regulatory Authority having jurisdiction over Prometic, which could reasonably be expected to have a material adverse effect on the Patents, the Products, Prometic or its ability to pay the Royalty Entitlement.

 

Page 6

 

 

(g)Intellectual Property. Schedule “A” attached hereto includes all of the Patents owned or controlled, as of the Effective Date, by Prometic and each of its Affiliates. As of the Effective Date, Prometic or its Affiliates, as applicable, are the sole owners of such Patents. As of the Effective Date, there is no pending litigation or, to the knowledge of Prometic, threat of litigation, that has been received by Prometic or any of its Affiliates that alleges that Prometic’s or its Affiliates’ activities with respect to the Patents or Products have infringed or misappropriated any of the intellectual property rights of any third party. As of the Effective Date, to the knowledge of Prometic, the exploitation of the Patents as currently contemplated by Prometic does not infringe any patent rights, or misappropriate any other intellectual property owned or licensed by a third party. As of the Effective Date, to the knowledge of Prometic, all patents and patent applications included in the Patents are valid and subsisting and Prometic has not received notice of any action, claim, suit, inquiry, investigation or other proceeding threatened, pending or ongoing, in each case that challenges, questions or threatens the validity or enforceability of any of the Patents. As of the Effective Date, to the knowledge of Prometic, no third party is infringing or misappropriating any Patents. The representations and warranties in this paragraph shall be repeated with respect to any additional patents or patent applications added (or required to be added) to Schedule “A” ([***] set forth in the definition of “Patents” or under Section 5(b)) on the date such schedule is updated (or required to be updated) under this Agreement (as if such representations and warranties had been made as of such date and replacing all references to “As of the Effective Date” or similar references in such representations and warranties with references to the date such schedule is updated (or required to be updated) under this Agreement).

(h)Commercial Sales. No Product is being commercially sold by Prometic as of the Effective Date.

(i)Licensing Agreements. As of the Effective Date, Prometic has entered into the Licensing Agreements listed in Schedule “B” attached hereto, and all sublicense agreement entered into by Prometic’s licensees under any Licensing Agreements are also listed in Schedule “B”. As of the Effective Date, each Licensing Agreement, and to the knowledge of Prometic, each sublicense agreement, is in full force and effect, and neither Prometic, nor to the knowledge of Prometic, any third party, is in default under any such agreement in any material respect. The representations and warranties in this paragraph shall be repeated with respect to any additional Licensing Agreement or sublicenses added (or required to be added) to Schedule “B” on the date that notice of such Licensing Agreement or sublicense is given (or required to be given) to SALP under Section 5(a) (as if such representations and warranties had been made as of such date and replacing all references to “As of the Effective Date” or similar references in such representations and warranties with references to the date notice of a Licensing Agreement or sublicense is given (or required to be given) to SALP under this Agreement).

(j)Finders’ Fees. There is no investment banker, broker, finder or other intermediary that has been retained by or is authorized to act on behalf of Prometic who might be entitled to any fee or commission from SALP or any of its Affiliates upon consummation of the transactions contemplated by this Agreement. 

	
4.
	
REPRESENTATIONS AND WARRANTIES OF BUYER

SALP hereby represents to each Prometic Party the following:

(a)Organization and Existence. SALP is duly organized, validly existing and in good standing under the laws of its jurisdiction of organization and has all applicable powers and all material governmental licenses, authorizations, consents and approvals required to carry on its business as now conducted.

(b)Corporate Authorization. The execution, delivery and performance by SALP of this Agreement and the consummation by SALP of the transactions contemplated hereby are within the powers of SALP and have been duly authorized by all necessary action on the part of SALP. This Agreement has been duly executed and delivered by SALP and constitutes a valid and binding agreement of SALP, subject to any limitation on enforcement under applicable laws relating to (i) bankruptcy, winding-up, insolvency, arrangement and other laws 

 

Page 7

 

 

of general application affecting the enforcement of creditors' rights and (ii) the discretion that a court may exercise in the granting of extraordinary remedies such as specific performance and injunction.

(c)Non-Contravention. The execution, delivery and performance by Prometic of this Agreement does not: (i) contravene or conflict with the constating documents of SALP; or (ii) contravene or conflict with or constitute a violation of any provision of any law or regulation binding upon or applicable to SALP that would have an adverse effect on SALP's ability to consummate the transactions contemplated by this Agreement.

(d)Finders’ Fees. There is no investment banker, broker, finder or other intermediary that has been retained by or is authorized to act on behalf of SALP who might be entitled to any fee or commission from Prometic or any of its Affiliates upon consummation of the transactions contemplated by this Agreement.

(e)Canadian Partnership. SALP is, and shall remain for the duration of this Agreement, a “Canadian partnership” for purposes of the Income Tax Act (Canada).

	
5.
	
COVENANTS

SALP and Prometic agree as follows:

(a)Licensing Agreements. Prometic will notify SALP in writing within thirty (30) days of the signature of any new Licensing Agreement (and within thirty (30) days after having become aware of the signature of any new sublicense of any rights granted under a Licensing Agreement) and shall provide SALP with a copy of any such Licensing Agreement within thirty (30) days of signature (and with a copy of any sublicense agreement received by Prometic or its Affiliates within thirty (30) days after receipt of such sublicense agreement). All Licensing Agreements shall (and shall require that any sublicense) be on bona fide arms-length commercial terms and shall be consistent with the terms of this Agreement and include all terms necessary to enable performance by Prometic of its obligations hereunder (including with respect to reporting rights, audit rights and confidentiality obligations). No Patent shall be held or encumbered by or in favour of, or issued, sold, assigned, transferred, licensed on an exclusive basis, encumbered, or disposed to, any Prometic Affiliate unless such Affiliate has executed an instrument in writing, in form and substance satisfactory to SALP, acting reasonably, under which it agrees to become a party to this Agreement as a “Prometic” party and agrees to be bound by all obligations of Prometic hereunder, and Schedule “C” shall be promptly updated (and in any event within 10 days) accordingly.

(b)Patents. The status of the Patents listed in Schedule “A” shall be updated within 45 days after the end of each fiscal quarter of each fiscal year, as applicable.

(c)Confidential Treatment. [***]. In the event of termination of this Agreement, SALP and Prometic shall immediately return to each other, or at the other party’s request, destroy all confidential information relating to the Royalty Entitlement, except that one copy of such information may be retained only for archival and compliance purposes (including for the purposes of enforcing the provisions of this Agreement). Documents and information shall not be considered confidential to the extent that the information or document: (i) is part of the public domain at the time of disclosure between the parties, (ii) subsequently becomes part of the public domain through no act or fault of the receiving party or its representatives, (iii) was known or was otherwise available to the receiving party prior to disclosure between the parties, (iv) was provided to the receiving party, without restriction, by a third party who was not under a duty of confidentiality respecting the information disclosed, or (v) was independently developed by or on behalf of the receiving party without reference to the confidential information.

(d)Public Announcement. Except as required by law or the rules and regulations of applicable Securities Regulators, the Parties agree not to issue any press release or make any public statement with respect to 

 

Page 8

 

 

SALP’s acquisition of the Royalty Entitlement. Any press release or public statement is required to comply with applicable securities regulations and, shall, to the extent possible, be a joint release, and in any event each Party shall be provided with a reasonable opportunity to comment on any press release or public statement made with respect to this Agreement.

(e)Notice of Certain Events. Prometic shall promptly (and in any event within 10 days) report to SALP in writing the occurrence of any events that could reasonably be expected to give rise to a right of Prometic to terminate this Agreement under Section 8 hereof, or that would cause any representation or warranty given by Prometic under Section 3 hereof to be untrue if such representation or warranty were required to be given as of the date of the event.

	
6.
	
PAYMENT OF ROYALTY, REPORTS, AUDIT RIGHTS

(a)Royalty Entitlement Payment and Reports. During the Term of this Agreement, Prometic will deliver to SALP within forty-five (45) days following the last day of each Quarter a written report stating the number of Products sold, Net Sales of Products (including itemized deductions per the definition of Net Sales), Licensing Revenues and Joint Venture Revenues for such Quarter on an entity per entity basis, and stating whether the Minimum Payment applies and any Minimum Amount. Each such report will be accompanied by the Royalty Entitlement payment due for such Quarter either by check or wire transfer pursuant to instructions received from SALP. Any Royalty Entitlement payment that is not paid when due shall bear interest at the interest rate of [***] per month. For certainty, Prometic shall not be required to deliver any report in respect of any month for which no amount is payable to SALP. The Royalty Entitlement payment due for a Quarter shall be based on the Royalty Entitlement percentage in force as of the date of receipt of the Licensing Revenues, Net Sales or Joint Venture Revenues as applicable for such Quarter, or the Minimum Payment for such Quarter, as applicable. 

[***] 

To the extent that the receipt of Licensing Revenues, Joint Venture Revenues or Net Sales following an increase in the Royalty Entitlement percentage results in any change to the written report described above that has previously been submitted by Prometic, then such written report shall promptly (and in any event within thirty (30) days) be amended and the amount of the Royalty Entitlement payment shall be accordingly increased, and such amended report will be accompanied by the increase in the Royalty Entitlement payment due either by check or wire transfer pursuant to instructions received from SALP. 

(b)Set-off of Minimum Amount.  Any Royalty Entitlement payment due for any Quarter by Prometic to SALP shall be set-off against the aggregate amount of all Minimum Amounts previously paid by Prometic to SALP that have not previously been so set off against (such that the Royalty Entitlement payment will be reduced by the aggregate amount of all Minimum Amounts previously paid by Prometic that have not previously been so applied to reduce the Royalty Entitlement payment for any Quarter); provided that the Royalty Entitlement in respect of any Quarter shall not be less than [***].

(c)Audit and Inspection Rights. Prometic shall maintain, during the Term of this Agreement and for at least three (3) years thereafter, true and accurate records and books of account sufficient and reasonably required for the computing and verification of all payments owed by Prometic to SALP, including records for Net Sales (and itemized deductions therefrom), Licensing Revenues, Joint Venture Revenues and number of Products sold, and to demonstrate Prometic’s compliance with its reporting obligations and payment obligations pursuant to Section 6(a). Prometic shall make such records available for inspection (which inspection shall be at the sole cost and expense of SALP) by an independent public accounting firm, during normal business hours upon reasonable advance notice, for the purpose of confirming Prometic’s compliance with its obligations under this Agreement. If in the written determination of such auditors there has been an under-reporting by Prometic of 

 

Page 9

 

 

more than five percent (5%) of the total amounts due during any Quarter, Prometic shall pay the costs of such audit in addition to all unpaid amounts then owing.

	
7.
	
SURVIVAL

(a)The confidentiality obligations contained herein shall survive the expiration or termination of this Agreement. 

(b)The representations and warranties contained herein shall survive for a period of two years from the date of this Agreement, and the representations and warranties contained in a certificate or notice delivered by Prometic or Prometic Life Sciences Inc. in accordance with Sections 2(a), 3(g) and 3(i) shall survive for a period of two years following the applicable milestone payment date or the date of such notice, as the case may be.

(c)Subject to Section 7(b), the expiration or termination of this Agreement shall not excuse any party hereto from its liability in respect of any breach hereof prior to such expiration or termination.

	
8.
	
TERM

(a)Term. The term of this Agreement shall commence on the Effective Date and shall continue until the earlier of (i) the mutual agreement in writing of the Parties to terminate this Agreement; (ii) November 30, 2019 provided that Prometic has not drawn the 2nd Advance under the Second Tranche; and (iii) the later of the expiration on a country-by-country basis of (1) the last Patent in the Territory and (2) any exclusivity period granted to Prometic or to any Prometic Affiliate (or to a licensee or sublicensee of Prometic or any Prometic Affiliate) pursuant to protection by “Orphan Drug” status (within the meaning of such term under the U.S. Orphan Drug Act) and/or any type of data exclusivity or data protection or any similar statutory or regulatory protection in the relevant country that provides exclusivity or any other protection or advantage vis-à-vis competitors in respect of a Product; in each case unless sooner terminated as provided herein, including as a result of Prometic and/or any Prometic Affiliate exercising its Buy-Out Right under Section 2(d). For greater certainty, a Minimum Payment made by Prometic to SALP shall not in any way be construed as to extend or renew the term of this Agreement beyond the term set forth in this Section 8(a).

(b)Termination for breach. If either Party commits a material breach of this Agreement, the non-breaching Party may notify the breaching Party in writing of such breach and breaching Party will have thirty (30) days after receipt of such notice to cure such breach to the non-breaching Party’s satisfaction, acting reasonably. If the breaching Party fails to cure such breach, the non-breaching Party may, at its option, terminate this Agreement at any time thereafter by sending the breaching Party written notice of termination. The notice of termination shall specify the effective date of the termination. No delay by a Party in exercising such right shall cause such Party to lose such termination right by laches, estoppel or any other legal theory.

(c)Effect of Termination. In the event that SALP exercises its termination right pursuant to Section 8(b), Prometic shall refund the Purchase Price paid by SALP and shall also pay to SALP any aggregate Royalty Entitlement amount that has accrued but not yet been paid to SALP hereunder prior to the effective date of termination. From and after the termination of this Agreement, Prometic shall cease to have any obligations or liabilities hereunder whatsoever, except for those provisions which by their terms or nature are intended to survive the termination of this Agreement.

(d)Refund Does Not Affect Set Off. In the event that (i) any interest owed by Prometic to SALP under the Loan Agreement (as amended by the Amendment), or (ii) any other liability or obligation of Prometic or any Prometic Affiliate, on the one hand, owed to SALP or any SALP Affiliate, on the other hand, under the Loan Agreement (as amended by the Amendment), is set off and extinguished in accordance with Section 2(b), any refund of any portion of the Purchase Price pursuant to Section 8(c) will not in any way affect or negate such 

 

Page 10

 

 

set off and extinguishment, and such interest or other liability or obligation under the Loan Agreement (as amended by the Amendment) will remain extinguished.

(e)Survival. All payment obligations accrued prior to the date of termination shall survive termination of this Agreement.

	
9.
	
Taxes. 

(a)Each of the Parties shall be liable for their respective taxes that become due and payable by each of them as a consequence of the transactions contemplated by this Agreement. All payments hereunder shall be made free of applicable withholding taxes and if any such taxes are applicable the payor shall gross up its payments to the recipient so that the recipient obtains net of withholding taxes the full amount paid to them. Neither party shall be liable to the other party for any taxes of the other party that may become due and payable as a consequence of the transactions contemplated by this Agreement. The amounts payable pursuant to this Agreement are exclusive of any applicable sales taxes, including, for greater certainty, GST, HST and QST (“Sales Tax”).

(b)The Parties agree that the Milestone Fees and the payment of the Royalty Entitlement (including any Minimum Payment) are not subject to Sales Tax. However, to the extent that a governmental authority finally determines by a non-appealable decision that the Milestone Fees are subject to Sales Tax, the Buyer shall promptly pay to Prometic the amount of such Sales Tax (including any applicable penalties and interest assessed against Prometic) as so finally determined by the applicable governmental authority; provided that SALP shall have the right to  assume at its own cost the conduct of any proceeding relating to any determination in respect of such Sales Tax. If Buyer does not assume the conduct of any such proceeding, Buyer shall reimburse Prometic for the reasonable legal, accounting and other professional costs and expenses incurred by Prometic in connection with any such proceedings.

	
10.
	
MISCELLANEOUS

(a)Assignment. This Agreement shall enure to the benefit of and be binding upon the parties hereto, their respective successors and any permitted assigns. Neither Party may assign its rights or obligations under this Agreement without the other Party’s prior written consent. Notwithstanding the foregoing, but subject to Sections 5(a) and 2(b), either Party may assign all or any part of its rights or obligations under this Agreement to an Affiliate by providing notice to the other Party, provided that such Affiliate agrees and undertakes to assume all of the assigning Party’s duties, responsibilities and liabilities (and provided further that in the case of Prometic, the Prometic assigning party shall continue to also be responsible for its duties, responsibilities and liabilities hereunder). Any other attempted assignment is void.

(b)Waiver. The failure of either party to complain of any default by the other Party or to enforce any of such Party’s rights, no matter how long such failure may continue, will not constitute a waiver of the Party’s rights under this Agreement. The waiver by either Party of any breach of any provision of this Agreement shall not be construed as a waiver of any subsequent breach of the same or any other provision. No part of this Agreement may be waived except by the further written agreement of the Parties.

(c)Headings. The headings of paragraphs and sections used in this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement unless the context requires otherwise.

(d)Notices. Any notice or other communication required or permitted to be given to a party hereunder shall be in writing and shall be given by facsimile or email, other electronic means or by hand‐delivery as hereinafter provided. Any such notice, if sent by facsimile or email, shall be deemed to have been received on 

 

Page 11

 

 

the Business Day after the day of sending, or if delivered by hand shall be deemed to have been received at the time it is delivered to the applicable address noted below. Notice of change of address shall also be governed by this Section. Notices and other communications to each party shall be addressed as follows:

Prometic:c/o Prometic Life Sciences Inc.

440 Armand – Frappier Blvd.
Suite 300, Laval, Quebec, H7V 4B4

Attention:[***]

With a copy to:

440 Armand – Frappier Blvd.
Suite 300, Laval, Quebec, H7V 4B4

Attention: [***]

 

	
 
	
SALP:
	
Structured Alpha LP
[***]

	
 
	
Attention:
	
[***]

 

With a copy (which shall be deemed not to constitute notice) to:

	
 
	

	
Torys LLP
[***]

[***] 

(e)Relationship. Neither Party is the agent, employee, or servant of the other. Neither Party shall have nor exercise any control or direction over the methods by which the other Party performs work or obligations under this Agreement. Further, nothing in this Agreement is intended to create any partnership, joint venture, lease, or equity relationship, expressly or by implication, between the Parties with the respect to the subject matter herein.

(f)Entire Agreement. This Agreement constitutes the final, complete and exclusive agreement between the Parties with respect to its subject matter and supersedes all past and contemporaneous agreements, promises, and understandings, whether oral or written, between the parties.

(g)Currency. All monetary amounts in this Agreement are stated in U.S. dollars.

(h)Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein. Each Party hereto irrevocably attorns and submits to the exclusive jurisdiction of the Ontario courts situated in the City of Toronto and waives objection to the venue of any Proceeding in such court or that such court provides an inconvenient forum. The Parties agree that they will not bring any proceedings relating to any issue arising from this Agreement in any court outside Ontario. Notwithstanding the foregoing, SALP may initiate, continue or otherwise bring a proceeding in a jurisdiction other than Ontario if SALP believes, in its sole discretion, that doing so will expedite or otherwise benefit its ability to enforce its rights under this Agreement.

 

Page 12

 

 

(i)Invalidity, etc. Each of the provisions contained in this Agreement is distinct and severable and a declaration of invalidity, illegality or unenforceability of any such provision or part thereof by a court of competent jurisdiction shall not affect the validity or enforceability of any other provision hereof.

(j)Counterparts. This Agreement may be signed in any number of counterparts, each of which shall be deemed to be an original, but all such separate counterparts shall together constitute one and the same instrument. Delivery of such counterparts may be made by fax or PDF via email, either of which will be deemed to have the legal effect of an original.

(k)Amendments. No amendment, restatement, replacement, supplement or other modification of this Agreement is effective unless it is in writing and signed by an officer of each of SALP and Prometic. Such amendment, restatement, replacement, supplement or modification shall be effective only in the specific instance and for the specific purpose for which it is given.

[signature page follows]

 

Page 13

 

 

IN WITNESS WHEREOF, the parties have executed this Royalty Stream Purchase Agreement as of the Effective Date.

 

				
	
 
	
 
	
 

PROMETIC BIOSCIENCES INC.

	
By:
	
/s/ Patrick Sartore

	
 
	
Name: Patrick Sartore
Title: Secretary 

	
 
	
 
	
 

 

PROMETIC LIFE SCIENCES INC.

	
By:
	
/s/ Pierre Laurin

	
 
	
Name: Pierre Laurin
Title: President and CEO

 

				
	
 
	
 
	
PROMETIC PHARMA SMT LIMITED

	
By:
	
/s/ Patrick Sartore

	
 
	
Name:Patrick Sartore
Title:

 

				
	
 
	
 
	
STRUCTURED ALPHA LP, by its general partner Thomvest Asset Management Inc.

	
By:
	
/s/ Stefan V. Clulow

	
 
	
Name:Stefan V. Clulow
Title:Chief Investment Officer and Management Director

 

 

 

 

Page 14

 

 

Schedule “A”
PATENTS

 

See attached.

 

Page 15

 

 

Schedule “B”
LICENSING AGREEMENTS

 

License agreement entered into on April 18, 2017 between Prometic Pharma SMT Limited, Prometic Biosciences Inc. and NANTCELL, INC. with respect to PBI-4419.

 

Page 16

 

 

Schedule “C”
PROMETIC PARTIES

Nil

 

Page 17

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00306-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00306-of-00352.parquet"}]]