Document:

EXHIBIT 10.5

 

EXECUTION VERSION

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

SUPPLY AGREEMENT

 

THIS SUPPLY AGREEMENT (the “Agreement”) is as entered into as of this 1st day of March, 2012 (“Effective Date”) between Omthera Pharmaceuticals, Inc., a corporation organized under the laws of Delaware and having a place of business at 707 State Road, Princeton, New Jersey, USA, 08540 (“Omthera”) and BioVectra Inc.,  a corporation organized under the laws of Prince Edward Island and having a place of business at 11 Aviation Avenue, Charlottetown, Prince Edward Island, C1E 0A1 Canada (“BioVectra”) (each individually a “Party” and collectively the “Parties”).

 

WHEREAS, Omthera wishes to purchase from BioVectra and BioVectra desires to sell to Omthera the Product (as hereinafter defined); and

 

WHEREAS, BioVectra has the technical and scientific experience and expertise necessary to perform manufacturing, packaging, analytical testing and/or quality assurance services for the manufacturing and bulk packaging of such Product, and to handle materials associated with manufacture of such Product in a safe and environmentally sound manner; and

 

WHEREAS, Omthera desires BioVectra to perform such services as set forth herein and manufacture such Product for Omthera, and BioVectra desires to perform such services and manufacture such Product for supply to Omthera or its designee, all on the terms and conditions set forth in this Agreement;

 

NOW, THEREFORE, in consideration of the mutual covenants and promises set forth herein, the Parties agree as follows:

 

1.                                      DEFINITIONS

 

The following terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement:

 

1.1                               “Act” means the United States Federal Food, Drug and Cosmetics Act, as amended, and the regulations promulgated under such Act.

 

1.2                               “Affiliate” means any corporation or non-corporate entity that controls, is controlled by, or is under common control with a Party.  For purposes of this Section 1.2, “control,” whether used as a noun or a verb, means the possession, directly or indirectly, of the power to affirmatively direct, or affirmatively cause the direction of, the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise.

 

1.3                               “Agreement” means this Supply Agreement and any Schedules appended hereto, as may be amended from time to time.

 

1.4                               “Applicable Laws” means (a) all applicable federal, provincial, state and local laws statutes, rules and regulations; (b) international guideline ICH Q7A; (c) the Act and all applicable regulations, guidelines and standards under FDA, Health Canada, Medicines and Healthcare Products Regulatory Agency and any other Regulatory Authority subscribing to ICH Q7A; (d) GMP and (e) any other

 

***Confidential Treatment Requested

 

 

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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

regulatory authority, standard, guideline, regulation or law as agreed upon in writing between the Parties.

 

1.5                               “BioVectra Manufacturing Know-How” will mean all data, Information and Know-How owned or controlled by BioVectra or any of its Affiliates prior to the Effective Date or developed or acquired by or for BioVectra or any of its Affiliates thereafter and relating to the manufacturing, processing, formulating, packaging, labeling, holding and quality control testing of Product (including any intermediate).

 

1.6                               “Certificate of Compliance” means a document signed by BioVectra’s authorized Quality Assurance representative indicating that each batch of Product was manufactured in compliance with GMP, and that all deviations were evaluated and closed for impact on Product.

 

1.7                               “Certificate of Origin” means the Certificate of Origin and BSE/TSE Declaration form for each batch of Product based on the certificate of origin received by Ocean Nutrition Canada Limited, or other qualified supplier of Material signed by BioVectra’s authorized Quality Assurance representative designating the country and species of the originating source of fish oil and certifying the originating source of fish oil is BSE/TSE free.

 

1.8                               “Change” or “Deviation” means any planned or unplanned deviation, variance or change.

 

1.9                               “COA”  means Certificate of Analysis that is signed by BioVectra’s authorized Quality Assurance representative certifying that a specific batch of Product conforms to the Specifications.

 

1.10                        “Confidential Information”  means all confidential or proprietary information, data and know-how of each Party, whether disclosed orally or visually or in written, graphic, electronic or other tangible form, which is disclosed by a Party or any of its Affiliates (the “Disclosing Party”) to the other Party or any of its Affiliates (the “Receiving Party”) or which the Receiving Party obtains in the course of its performance pursuant to this Agreement, and which: (a) if in written, graphic, electronic or other tangible form, is labeled as confidential or proprietary; (b) if disclosed orally or visually, is identified as confidential or proprietary at the time of disclosure and is confirmed to be confidential or proprietary by the Disclosing Party in writing to the Receiving Party within thirty (30) calendar days of such disclosure; or (c) by its nature, should reasonably be considered to be confidential or proprietary.  For clarity, Confidential Information shall include (a) any information relating to the product plans, specifications, designs, costs, prices and names, finances, marketing plans, business opportunities, personnel, research, development, Intellectual Property or know-how of a Party, regardless of when such information was revealed or disclosed; and (b) the terms and conditions of this Agreement (which terms and conditions will be treated as the Confidential

 

	
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BioVectra
    

 

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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Information of both Parties).

 

1.11                        “FDA”  means the United States Food and Drug Administration or any successor entity thereof having or performing substantially the same function.

 

1.12                        “Finished Product” means any product produced by Omthera, a (sub)licensee or an ultimate customer of Omthera that incorporates or includes Product as an ingredient or an intermediary, including Epanova.

 

1.13                        “Firm Order” means a binding commitment in writing made by Omthera to purchase Product in accordance with Section 5.

 

1.14                        “GMP” means all laws, guidelines and regulations applicable to the manufacture of Product including the current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, as the same may be amended or re-enacted from time to time, and international guidelines and regulations such as ICH Q7A.

 

1.15                        “Intellectual Property” means any and all patents; patent applications; all provisional, divisional, continuations, renewals, continuations-in-part, re-examinations, patents of addition, supplementary protection certificates, extensions, letters of patent, registration or confirmation patents and reissues with respect to any patents or patent applications; any Know-How, data, technology, inventions, copyrights, industrial property and technical information; and any and all rights in or to any of the foregoing.

 

1.16                        “Know-How” means all non-patented proprietary information, inventions, discoveries, designs, developments, techniques, materials, processes, manufactures, compositions of matter or methods of use and trade secrets, whether or not patentable or copyrightable.

 

1.17                        “Latent Defect” means a defect attributable to an act or omission of BioVectra, existing in the Product at the time of delivery by BioVectra to the shipping destination; which did not exist at the start of the BioVectra manufacturing process; and was not reasonably discoverable upon visual inspection or testing (as defined in the Specifications) and which renders the Product or the derived product not suitable for pharmaceutical use.

 

1.18                        “Material” means the specified fish derived Omega-3 oils in ethyl ester meeting the Material Specifications. The Material shall be manufactured by Ocean Nutrition Canada Limited or any other qualified supplier and provided by Omthera to BioVectra.

 

1.19                        “Material Specifications” means the specifications set out in Schedule 1 attached to this Agreement.

 

1.20                        “Marketing Authorization” means, with respect to a Product, all necessary

 

	
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3

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

registrations, listings, approvals or licenses by the applicable Regulatory Authority for the importation, storage, promotion, sale or distribution of such Product.

 

1.21                        “Omthera Manufacturing Know-How” will mean all data, Information and Know-How owned or controlled by Omthera or its Affiliates, licensors, (sub)licensees or other collaborators prior to the Effective Date or developed or acquired by or for Omthera or its Affiliates, licensors, (sub)licensees or other collaborators thereafter and relating to the manufacturing, processing, formulating, packaging, labeling, holding and quality control testing of any Product (including any intermediate).

 

1.22                        “Product” means Omefas Drug substance (Omega-3 free fatty acid concentrate) meeting the Product Specifications set out in Schedule 1, attached hereto.

 

1.23                        “Product Recall” means any recall, withdrawal, field correction or other action to recover possession of quantities of the Product shipped or sold to Third Parties resulting in the event that (i) any Regulatory Authority issues a request, directive or order that any Product or drug products derived from Product be recalled, (ii) a court of competent jurisdiction orders such a recall, (iii) Omthera reasonably determines after consultation with BioVectra that any Products should be recalled because they do not conform to the Product Specifications or other requirements of this Agreement at the time of shipment by BioVectra or (iv) Omthera reasonably determines that any Products should be recalled for any reason.

 

1.24                        “Purchase Order” means a written order for the purchase of Product duly executed by Omthera and transferred to BioVectra via mail, facsimile or electronically, and setting forth the quantity of Product ordered, the required delivery dates, the price for the Product, the Purchase Order number, the name of the requester, and any special terms and conditions relevant to the particular Purchase Order (special terms and conditions are those that are not preprinted).

 

1.25                        “Regulatory Authority” means the FDA, European Medicines Agency, any regulatory authority that subscribes to ICHQ7, and any other regulatory authority or governmental authority regulating the marketing or sale of pharmaceutical substances in such country or region that the parties have agreed upon.

 

1.26                        “Quarter”  means the period of three consecutive calendar months ending 31 March, 30 June, 30 September and 31 December.

 

1.27                        “Section” means a Section of this Agreement.

 

1.28                        “Specifications” means the specifications and quality assurance and other testing for the Product and Material, as specified, which are attached hereto in Schedule 1, and made a part hereof, as determined in accordance with the analytical methodology set forth therein, as such Specifications may be amended from time to time in writing by mutual agreement of the Parties, [...***...]. If an amendment to the Specification is requested by BioVectra, [...***...]

 

	
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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

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

 

1.29                        “Territory” shall be worldwide.

 

1.30                        “Third Party” means any party other than Omthera, BioVectra and their respective Affiliates and agents.

 

2.                                      SUPPLY OF PRODUCT

 

2.1                               Supply and Purchase.  BioVectra agrees to manufacture for and supply to Omthera or its designee on an exclusive basis such quantities of Product as Omthera may order from BioVectra, and Omthera agrees to purchase such quantities of Product from BioVectra, in accordance with the terms and conditions of this Agreement.  Omthera shall be obligated to purchase a minimum of [...***...] (“Minimum Order Quantity”) during the Supply Term (defined below in Section 3.1) of this Agreement.

 

2.2                               Supply of Material by Omthera.  Omthera shall supply Material to BioVectra from which BioVectra shall manufacture Product.  The Material provided by Omthera shall meet the Material Specifications.  Omthera shall provide BioVectra sufficient quantities of Material to meet Omthera’s orders hereunder.  The Material shall be delivered to BioVectra free of charge.  The Parties shall agree upon a delivery schedule for receipt of the Material in a timely manner to fulfill Purchase Orders hereunder.  Upon receipt, BioVectra shall perform agreed incoming quality control testing and will consult with Omthera regarding any quality issues.  Failure of Omthera to supply Material in accordance with the Material Specifications and in compliance with the quality agreement to be executed by the Parties as set out in Section 2.9 herein shall not negate any of Omthera’s obligations hereunder.

 

2.3                               Ocean Nutrition Canada.  Omthera covenants that it has the right to retain BioVectra to manufacture Product from Material without further permission of Ocean Nutrition Canada, Limited. BioVectra shall not be obligated to pay Ocean Nutrition Canada, Limited, Omthera or any other Third Party for the right to manufacture Product from Material supplied by Ocean Nutrition Canada, Limited.

 

2.4                               Construction of Facility.  BioVectra will construct a  one hundred metric ton facility (“100MT Facility”) to manufacture the Product.  BioVectra will commence construction upon the Effective Date and complete construction within [...***...].  Omthera will pay for the actual out-of-pocket construction costs up to five million dollars (US $5,000,000) [...***...]

 

	
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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...].  Within seven (7) days after the Effective Date, Omthera shall review with BioVectra the basis of design plan.  Within fifteen (15) days after the Effective Date, Omthera shall approve the basis of design plan.  BioVectra shall invoice Omthera on a monthly basis throughout the construction, and Omthera shall pay invoices within [...***...] of receipt of a proper invoice.  On the Effective Date, Omthera shall pay BioVectra 100MT.  At completion of equipment validation BioVectra shall allow Omthera to audit its books and records relating specifically to the construction of the 100MT Facility to confirm the costs of construction.

 

2.5                               Termination of Construction.  Omthera may terminate this Agreement during construction of the 100MT Facility due to the receipt of negative results on the Phase III Product study, if results cause Omthera to abandon its filing of the NDA for Finished Product.  The results of the Phase III Product study are expected to be released in [...***...].  Within thirty (30) days of release of results and no later than [...***...], Omthera shall notify BioVectra promptly of the results and subsequent decision to abandon its filing of the NDA for Finished Product.  Upon termination under these circumstances, Omthera shall be responsible for [...***...].  This right of termination extends only until [...***...].

 

2.6                               Equipment.  Omthera will own all equipment installed in the 100MT Facility listed in Schedule 2, attached hereto, as may be amended and updated during the Term as equipment is acquired.  [...***...].  [...***...] shall be responsible for any replacement equipment that may be required during the Term, except for normal wear and tear covered under maintenance.  At termination of this Agreement, Omthera will offer to sell the equipment to BioVectra.  If BioVectra chooses not to accept the offer, BioVectra shall provide Omthera with an estimate of the cost of removal and Omthera will be responsible for the removal of the equipment.  BioVectra will commence removal of the equipment promptly following the end of the Term, and Omthera shall ship equipment to its destination of choice within thirty (30) days of removal.  Omthera’s responsibility for payment of expenses of removal under this Section 2.6 shall be limited to [...***...].  During the Term, BioVectra may utilize its own equipment in the manufacture of the Product, which equipment will not be listed in Schedule 2, and to which ownership remains with BioVectra.  BioVectra will update the Joint Project Team in writing if any BioVectra equipment is used in the 100MT Facility.

 

	
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***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

2.7                               Maintenance of Equipment.  BioVectra shall be responsible for maintaining, validating and calibrating Omthera equipment (and any other BioVectra equipment required to manufacture Product) in good working order.  Maintenance required of BioVectra includes, but is not limited to, preventative maintenance, calibration and repairs.

 

2.8                               Regulatory Approval.  The Product manufactured in the 100MT Facility will be included in Omthera’s Marketing Authorization. BioVectra will provide to Omthera such information and assistance relating to the manufacture of Product as Omthera may reasonably require for purposes of applying for and maintaining all Marketing Authorizations for the Product in the Territory, including without limitation providing Omthera with all reports, authorizations, certificates, methodologies, and other documentation in the possession or under the control of BioVectra or its Affiliates relating to the manufacture and supply of Product (or any component thereof).  The documentation provided by BioVectra to Omthera shall not be used for any purpose other than as specified herein.

 

2.9                               Quality Agreement.  Omthera and BioVectra will enter into a quality agreement setting out the responsibilities of both Parties with respect to the Product within six (6) months of the Effective Date (“Quality Agreement”).  Omthera will also enter into a quality agreement with Ocean Nutrition Canada, Limited, or any other supplier of Material, and BioVectra relating to the Supply of the Material (“Material Quality Agreement”).  The Material Quality Agreement shall specify that BioVectra will have the right to ensure controls to assure the required compliance from the Material supplier are in place over the manufacture, testing and release of Material to ensure compliance with the quality standards required for GMP and approved guidelines pursuant to BioVectra’s quality system.

 

2.10                        Exclusivity.    During the Term, without the prior written consent of Omthera, BioVectra and its Affiliates shall not develop, manufacture, or supply any other product (other than for Omthera, its Affiliates and licensees) using the 100 MT Facility; and shall not develop, market, sell or supply any person or entity (other than for Omthera, its Affiliates and licensees), or license or enable any others to do the same, with [...***...].  If BioVectra has contracted with a third party but such contract would be in violation of this Section 2.10 (for example [...***...], then BioVectra shall comply with this Section 2.10[...***...]

 

	
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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

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

 

2.11                        Joint Project Team.  The Parties shall establish a Joint Project Team to oversee the Parties’ activities hereunder which shall include, but not be limited to, review of the construction of the 100MT Facility including review and approval of the process design and the validation/qualification plans; review of the progress of the Marketing Authorization; discussion and review of timelines of regulatory submissions, launch of Product, and supply chain management including supply of Material, forecasts, placement of purchase orders, and delivery of Product. Each Party shall appoint an equal number of representatives to serve on the Joint Project Team, one from each Party of which shall serve as project manager and be the recipient of communications pursuant to this Agreement. The Joint Project Team will meet no less often than quarterly for the Term.  BioVectra will have the right to evaluate the regulatory submission plan and will assess feasibility for meeting the compliance requirements for submission in countries which have not subscribed to international guideline ICHQ7.

 

2.12                        Applicability and Hierarchy of Terms.  The terms and conditions of this Agreement shall apply to any Purchase Order issued by Omthera to BioVectra during the Term of this Agreement for the Product that is the subject of this Agreement, whether or not this Agreement or its terms and conditions are expressly referenced in the Purchase Order.  In the event of a conflict between the pre-printed terms provided in any Purchase Order and the terms of this Agreement, the terms of this Agreement shall prevail.

 

3.                                      TERM AND TERMINATION

 

3.1                               Term.  This Agreement shall commence on the Effective Date and unless terminated earlier in accordance with the terms herein, shall continue in force until the fifth anniversary of the commencement of commercial supply (“Term”).  Commercial supply will commence within thirty (30) days of submission of final process validation report in support of the 100 MT Facility (“Supply Term”).  The Term may be extended for additional one (1) year periods upon agreement in writing between the Parties at least six (6) months prior to the end of the existing Term.

 

3.2                               Termination for Cause.  Without prejudice to any other available legal or equitable rights or remedies, the Parties may terminate this Agreement immediately upon written notice to the other Party as follows:

 

3.2.1                     Material Breach.  Either Party may terminate this Agreement in the event of the material breach by the other Party of the terms and conditions hereof (“Default”), through no fault of the non-Defaulting Party, which remains uncured ninety (90) calendar days after the non-Defaulting Party provides written notice of such Default to the Defaulting Party; provided however, that in the event that the Defaulting Party reasonably believes that the Default is

 

	
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***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

incapable of being cured within such ninety (90) day period, then the Defaulting party shall provide written notice to the non-Defaulting Party within seven (7) calendar days from the date of the notice of such Default, specifying that such Default is not capable of being cured within such period and the actions the Defaulting Party is taking to diligently cure such Default, and the non-Defaulting Party may, in its sole discretion, agree in writing to extend the time period for curing such Default for up to an additional thirty (30) calendar days or such time as is reasonably necessary to cure such Default.

 

3.2.2                     Insolvency; Bankruptcy.  Either Party may terminate this Agreement in the event that the other Party (a) becomes insolvent; (b) makes an assignment for the benefit of creditors; (c) files or has filed against it a petition in bankruptcy; (d) has a receiver appointed for its assets; or (e) is dissolved or liquidated.  If the Agreement is terminated for Omthera’s insolvency or bankruptcy hereunder, the equipment listed in Schedule 2 shall be deemed to have been transferred to BioVectra one day prior to the insolvency, assignment, filing, appointment, dissolution or liquidation event.

 

3.3                               Termination For Commercialization Issues.  Omthera may terminate this Agreement without cause immediately upon notice to BioVectra that either (a) the application for Marketing Authorization with the FDA for Finished Product has been rejected and Omthera has abandoned any attempt to receive approval; or (b) after receipt of Market Authorization, Omthera, its Affiliates or licensees have abandoned the sale, or otherwise commercialization of Finished Product due to market conditions.  Upon receipt of notice of termination from Omthera pursuant to this provision, BioVectra will immediately plan for a shutdown of all activities relating to the Product and will take reasonable steps to eliminate unnecessary expenditures.  Omthera shall be responsible for [...***...].  BioVectra shall invoice Omthera for all such expenses incurred under this Section 3.3, along with supporting documentation for such expenses, within sixty (60) days of the termination date.  Omthera shall pay such amounts within thirty (30) days of receipt of a proper invoice and conforming documentation.  Thereafter, Omthera shall have no further payment obligation to BioVectra.

 

3.4                               Effect of Termination or Expiration.

 

3.4.1                     In the event of any termination under this Section 3, the day that is the effective date of termination shall be the last day of the Term.

 

	
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***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

3.4.2                     If this Agreement is terminated by Omthera under Section 3.2 , or if this Agreement expires because the Term is not extended as provided in Section 3.1, then BioVectra and its Affiliates shall not [...***...].

 

3.4.3                     Sections 1, 2.3, 2.5, 2.6, 3, 4.2, 5.3, 5.6, 6, 7, 8, 9, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.10, 10.11, 11, 12, 13, and 14 will survive the expiration or termination of this Agreement.  All accrued rights and obligations of the Parties shall survive the expiration or termination of this Agreement.

 

4.                                      PRICE AND PAYMENT

 

4.1                               Price of Product.  The price for Product provided hereunder shall be as set forth in Schedule 3 to this Agreement.  The price for Product may only be adjusted as provided in Schedule 3 hereto.

 

4.2                               Billing and Payment.  As a deposit against Purchase Orders, each quarter during the Supply Term, Omthera shall pay BioVectra [...***...].  BioVectra shall invoice Omthera for deposit amounts thirty (30) days prior to the start of each quarter with invoices due within thirty (30) days and no later than the first day of the quarter.  Invoices for the remainder of payment accompanying shipment of Product are due within thirty (30) days of invoice date.  The deposit shall be applied pro rata to the Product delivered against the Purchase Order. All amounts payable by Omthera to BioVectra will be priced and paid in US Dollars by wire transfer in immediately available funds to an account designated by BioVectra.

 

5.                                      FORECASTS AND FIRM ORDERS

 

5.1                               Forecasts.   Omthera shall provide to BioVectra [...***...] forecasts of its estimated requirements for Product (“Forecast”).  Omthera shall provide such Forecasts to BioVectra at least [...***...] and such Forecasts shall provide an estimate of Omthera’s requirements for Product for  [...***...]. Except as provided in Section 5.2 below, such Forecasts shall be non-binding and estimates for planning purposes only and shall not constitute commitments by Omthera to purchase Product.

 

5.2                               Firm Orders.  Omthera will submit to BioVectra [...***...] purchase order for Product, specifying the quantities orders, the delivery destination, and shipping instructions (each a “Purchase Order”).  The Purchase Order shall include a detailed [...***...] delivery schedule which may be reviewed and amended as agreed to by the Joint Project Team.  Should Omthera require additional Product Omthera

 

	
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***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

may submit Purchase Orders to BioVectra in writing [...***...] prior to the requested delivery date. BioVectra will make reasonable commercial efforts to supply Omthera with the additional quantities of Product.   Omthera shall ensure that BioVectra has sufficient Materials in stock to fulfill Purchase Orders issued hereunder.  The Parties recognize that the 100MT Facility [...***...].

 

5.3                               Minimum Order Quantity.  Should Omthera fail to purchase the Minimum Order Quantity in any given year during the Supply Term, at the end of the year, BioVectra will invoice Omthera for  [...***...].  Omthera shall remit payment within thirty (30) days of invoice date.

 

5.4                               Subsequent Year Credit Back.  For each supply year immediately after a year when BioVectra invoices Omthera in accordance with Section 5.3, BioVectra will provide to Omthera a credit equal to  [...***...].

 

6.                                      DELIVERY; ACCEPTANCE; TITLE; RISK OF LOSS

 

6.1                               Delivery of Product.  BioVectra will deliver Product to Omthera FCA, Charlottetown, PEI (INCOTERMS 2000).  BioVectra will arrange for the shipment of Product including insurance, customs and clearance to a designated delivery location specified by Omthera, at Omthera’s expense.  Bio Vectra will provide documents for export and support the inspection and export process.  BioVectra shall ship Product [...***...].  BioVectra shall provide a COA, Certificate of Origin and a Certificate of Compliance with each shipment of Product.

 

6.2                               Title and Risk of Loss.  Title to and risk of loss of or damage to the Product sold hereunder shall pass to Omthera upon loading of the Product at the 100MT Facility in Charlottetown, PEI.  Omthera shall assume the risk of loss of or damage to the Product after such loading of the Product at BioVectra, except to the extent that such loss or damage results from the negligence or willful misconduct of BioVectra or its representatives, for which BioVectra shall retain the risk of loss of or damage to Product.

 

6.3                               Acceptance; Rejection.  All Product delivered by BioVectra to Omthera or its designee shall be subject to inspection by or on behalf of Omthera.  Omthera may, on written notice to BioVectra within  [...***...], reject any Product that does not conform to the Product warranties set out in Section 7.1.  Omthera shall [...***...] notify BioVectra upon discovery of

 

	
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***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

any Latent Defects in the Product.  Payment for Product by Omthera shall not constitute acceptance thereof.  For clarity, Omthera may revoke its acceptance of any Product in the event that any Latent Defects are discovered after acceptance by Omthera.  BioVectra will notify Omthera immediately upon discovery of a Latent Defect by BioVectra or any of its agents.

 

7.                                      REPRESENTATIONS AND WARRANTIES

 

7.1                               Warranties by BioVectra.  BioVectra represents and warrants to Omthera that:

 

7.1.1                     Product.  All Product provided to Omthera by BioVectra pursuant to this Agreement:

 

(a)                     Will conform in all respects with the Product Specifications;

 

(b)                     Will conform with the Quality Agreement; and

 

(c)                      Will conform to and will be manufactured, packaged, labeled, stored and shipped in conformity the requirements of the applicable Regulatory Authorities and with all Applicable Laws (including GMP).

 

7.2                               Title.  BioVectra has good title to all Product provided to Omthera pursuant to this Agreement and passes such title to Omthera free and clear of any security interests, liens, or other encumbrances.

 

7.3                               Debarment.  BioVectra is not debarred under subsections 306(a) or (b) of the Act and that it has not and will not use in any capacity the services of any person or entity debarred under such law with respect to its performance of this Agreement.  BioVectra will immediately notify Omthera in writing in the event that it or any such person or entity is debarred during the Term.

 

7.4                               No Conflict.  The execution, delivery and performance of this Agreement by BioVectra does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, and does not violate any law or regulation of any court, governmental body or administrative or other agency having authority over it; BioVectra is not currently a party to, and during the Term will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement.

 

7.5                               Authority.  BioVectra is validly existing and in good standing under the laws of the province of its incorporation and has the corporate power and authority to enter into this Agreement.  This Agreement has been duly executed and delivered by BioVectra and constitutes the valid and binding obligation of BioVectra, enforceable against it in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles.  The execution, delivery, and performance of this Agreement have been duly authorized by all necessary action on the part of 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

12

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

BioVectra, its officers and directors.

 

7.6                               Permits.  BioVectra maintains all valid governmental and regulatory permits and licenses as required to procedure and deliver Product in accordance with this Agreement.

 

7.7                               Breach of Warranty by BioVectra.  In the event that any Product does not meet any of BioVectra’s warranties, BioVectra shall replace or reprocess (if permitted within the regulatory constraints) the non-conforming Product as soon as practicable.  BioVectra will be responsible for all the costs of replacing non-conforming Product (including replacement Material).

 

7.8                               Independent Laboratory Testing.  If Omthera and BioVectra are unable to agree as to whether any Product conforms to the Product Specifications for such Product, the Parties shall cooperate to have the Product in dispute analyzed by an independent testing laboratory of recognized repute selected by BioVectra and approved by Omthera, which approval shall not be unreasonably withheld, conditioned or delayed.  The results of such laboratory testing shall be final and binding on the Parties on the issue of conformance of the Product to the Product Specifications.  If the Product is determined to so conform, then Omthera shall bear the cost of the independent laboratory testing and pay for the Product in accordance with this Agreement.  If the Product is determined not to conform, then BioVectra shall bear the cost of the independent laboratory testing, and BioVectra shall, at Omthera’s sole discretion, within thirty (30) calendar days of the date of such determination, either replace the rejected Product at no cost to Omthera or promptly refund to Omthera the price paid for such Product.

 

7.9                               Warranties by Omthera.  Omthera represents and warrants to BioVectra that:

 

7.10                        No Conflict.  The execution, delivery and performance of this Agreement by Omthera does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, and does not violate any law or regulation of any court, governmental body or administrative or other agency having authority over it; Omthera is not currently a party to, and during the Term will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement.

 

7.11                        Authority.  Omthera is validly existing and in good standing under the laws of the state of its incorporation and has the corporate power and authority to enter into this Agreement.  This Agreement has been duly executed and delivered by Omthera and constitutes the valid and binding obligation of Omthera, enforceable against it in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles.  The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Omthera, its 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

13

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

officers and directors.

 

7.12                        Material.  All Material provided by Omthera to BioVectra will conform to the Material Specifications and the Material Quality Agreement.

 

7.13                        Right to Manufacture.  Omthera has the right to have BioVectra manufacture Product from Material manufactured by Ocean Nutrition Canada, Limited in accordance with the terms and conditions of this Agreement free of any obligations to Ocean Nutrition Canada, Limited which might, in any way, affect BioVectra or the obligations of either BioVectra or Omthera under this Agreement.

 

8.                                      PRODUCT RECALLS

 

8.1                               Cooperation.  In the event of any Product Recall, the Parties shall take all appropriate corrective actions and shall cooperate in the investigations and all necessary activities surrounding the Product Recall. It is understood that Omthera has final authority to voluntarily recall the product.

 

8.2                               Consultation.  In the event that BioVectra or Omthera determines that Product should be recalled, the Parties shall consult with each other prior to taking any corrective actions.  Given that in the marketplace the Product is or will be associated with Omthera, in no event shall BioVectra institute a Product Recall without the prior written approval of an officer of Omthera.

 

8.3                               Product Recall Caused by BioVectra.  To the extent that any Product Recall results from any cause or event arising from the Product not conforming to the Product Specifications, the Quality Agreement, the requirements of applicable Regulatory Authorities, GMP requirements or all Applicable Laws, by any breach of BioVectra’s warranties, or otherwise by the acts or omissions of BioVectra or its Affiliates or agents, BioVectra shall be responsible for all expenses of such Product Recall.

 

8.4                               Product Recall Caused by Omthera.  To the extent that any Product Recall results from any cause or event arising from the Product Specifications, the Material supplied by or on behalf of Omthera, marketing, distribution, shipment, handling (after title passes to Omthera) or sale of the recalled Product by Omthera or its Affiliates or designee after delivery, or the negligence of Omthera or its Affiliates or designee upon delivery, Omthera shall be responsible for all expenses of such Product Recall.

 

8.5                               Disputes Regarding Cause of Product Recall.  If the Parties are unable to agree as to which Party’s acts or omissions gave rise to a Product Recall, such dispute shall be referred for decision to a mutually agreed upon independent expert of recognized repute (acting as an expert and not as an arbitrator, and who may be an attorney knowledgeable in FDA/pharmaceutical product recall law) selected by Omthera and approved by BioVectra, which approval shall not be unreasonably withheld, conditioned or delayed.  The results of such independent expert shall be 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

14

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

final and binding on the Parties on the issue of which Party’s acts or omissions gave rise to the Product Recall.  The costs of such independent expert shall be borne by the Party determined to be responsible for the Product Recall.

 

8.6                               Notification Regarding Product Recall.  Subject to Section 8.2 above, in the event that any Product Recall is required because Product violates Applicable Laws,  agreed upon Product Specifications, the Marketing Authorization pertaining to the Product, or is deemed unacceptable for some other reason, whether or not such action is requested by any Regulatory Authority, the initiating Party shall notify the other Party as soon as possible, but not later than the end of the next business day following the decision to implement such action.

 

9.                                      QUALITY ASSURANCE

 

9.1                               Change Control.  BioVectra will utilize a documented system of procedures for the control of changes to raw materials, packaging materials, suppliers, equipment, manufacturing methods, Product, intermediates and raw materials specifications, sampling, test methods, and release requirements, consistent with GMPs, all Applicable Laws, including the Marketing Authorization pertaining to the Product, and industry standards.  BioVectra shall not implement any Change without the express prior written approval of Omthera.  The Parties will provide written responses to requests from the other pursuant to this Section 9.1 as soon as commercially possible but in no event more than ten (10) business days from receipt of the request from the other Party hereto.  Updates to Marketing Authorizations pertaining to the Product are the responsibility of Omthera or its designee.

 

9.2                               Raw Materials.

 

9.2.1                     Procurement of Raw Materials.  BioVectra will utilize a documented system of procedures to evaluate, qualify and approve raw materials and suppliers. BioVectra is responsible for procuring suitable raw materials other than the Material from the approved and qualified sources.

 

9.2.2                     Inspection and Testing of Raw Materials.  BioVectra must utilize documented material inspection plans and testing procedures.  The results of this inspection and testing must be in accordance with BioVectra established specifications and the Marketing Authorizations pertaining to the Product.  BioVectra shall inspect all containers of raw materials (including Material) promptly upon receipt by BioVectra. BioVectra will inspect and/or test all raw materials on a batch-by-batch basis. BioVectra may accept and release certain starting materials utilizing the COA with abbreviated or no additional testing.  However, a minimum of an identification test is required unless the material is too hazardous or reactive to sample. BioVectra will only use approved suppliers, per BioVectra’s quality system.

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

15

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

9.2.3                     Storage and Handling of Raw Materials.  BioVectra agrees to store and handle the materials under appropriate conditions, consistent with GMPs, all Applicable Laws, the Marketing Authorizations pertaining to the Product, and industry standards.  BioVectra agrees to store Product labeling materials under appropriate controlled and secured conditions, consistent with GMPs, all Applicable Laws, the Marketing Authorizations pertaining to the Product, and industry standards.

 

9.3                               Product Specifications.  BioVectra will manufacture, package, label and handle all Product in conformance with, and in order for the Product to be in conformance with, the Product Specifications and the Marketing Authorizations pertaining to the Product.  Any changes to the Product Specifications will be made in accordance with the Quality Agreement, and[...***...].

 

9.4                               Manufacturing and Packaging of Product.  BioVectra shall manufacture, package, and label all Product in accordance with specific procedures and instructions consistent with GMPs, all Applicable Laws, the Marketing Authorizations pertaining to the Product, and industry standards.  BioVectra will prepare all appropriate and required manufacturing and packaging batch documentation for each batch of Product manufactured pursuant to this Agreement.   BioVectra shall retain such batch documentation in accordance with any document retention schedules provided by Omthera and as required in order to comply with Applicable Laws.  BioVectra will make any such batch documentation available for review and inspection by Omthera and/or any regulatory personnel, and BioVectra shall provide to Omthera all such batch documentation upon the expiration or termination of this Agreement or upon request by Omthera.

 

BioVectra will destroy any co-streams, waste material or labeling materials in a secure legal manner including in accordance with Applicable Laws, including environmental laws, in order to prevent unauthorized use and/or environmental problems.

 

9.5                               Inspection and Testing of Product.  BioVectra will perform the inspection and testing of Product as provided in the Quality Agreement.  Omthera reserves the right to inspect and/or test all batches of the Product delivered to Omthera or any Omthera designee.  BioVectra will make available for Omthera’s review the (i) executed batch records, (ii) all testing results conducted by BioVectra and/or independent testing labs contracted by BioVectra, (iii) deviation final reports, and (iv) any other associated documentation mutually agreed to by both Parties for each batch of Product delivered.

 

9.6                               Notification and Approval of Deviations.  BioVectra will have a documented system for handling deviations, deviation investigations, and corrective actions.  All deviations will be investigated and fully documented by BioVectra.  BioVectra is to notify Omthera of any deviations according to the Quality Agreement.

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

16

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

BioVectra will retain such documentation as part of the batch documentation for the batch affected.

 

9.7                               Release and Shipment of Product.  BioVectra has the responsibility to release the Product for shipment to Omthera or its designee, provided, however, that if Product does not meet the Product Specifications, in all respects, the Product can be released only with the prior written consent of Omthera.

 

BioVectra will not ship any Product until the Product is released by its Quality Assurance department.

 

9.8                               Retained Samples of Product.  BioVectra shall retain samples of all Product batches in accordance with the retention schedule mutually agreed upon but for no less than [...***...].  The amount of such retained samples shall be of sufficient quantity to conduct at least full Product Specification analyses in duplicate.  BioVectra shall store the retained samples under appropriate Product label storage conditions in a secure area and in a suitable storage facility, consistent with GMPs, all Applicable Laws, and industry standards.  All such samples shall be available for inspection by Omthera during any audit by Omthera of BioVectra’s facilities or upon reasonable notice to BioVectra by Omthera.

 

9.9                               Storage of Product.  BioVectra agrees to store the Product under appropriate Product storage conditions and in a secure area, consistent with GMPs, all Applicable Laws, the Marketing Authorizations pertaining to the Product, and industry standards.

 

9.10                        Complaints about the Product.  BioVectra will have a documented system to receive, communicate with Omthera, investigate, and resolve all complaints related to Product.  BioVectra will investigate the complaints as requested by Omthera and provide a written report on the results of the investigation to Omthera within thirty (30) calendar days.  If necessary, Omthera will communicate with the customers and/or the Regulatory Authorities the results of the complaint investigation.

 

9.11                        Returned Goods.  BioVectra will have a documented system for handling returned goods, consistent with GMPs, all Applicable Laws, and industry standards.

 

9.12        Audits and Inspections of Facilities and Product.  BioVectra will notify Omthera of any inspections of BioVectra’s facilities used in the manufacture or storage of Product, or other actions that could potentially impact Product, by any Regulatory Authorities or other enforcement entities.  BioVectra will provide Omthera with a written summary describing all results of inspections within thirty (30) days after the visit or inquiry. If any inspection is specifically related to the Product, BioVectra shall promptly inform Omthera and give Omthera representatives the opportunity to participate, at Omthera’s expense, in the inspection.

 

Omthera reserves the right to audit BioVectra’s facilities, systems, and documentation as they relate to the manufacture and control of Product, and to 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

17

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

assure compliance with this Agreement, including but not limited to Product manufacturing, storage, quality control, environmental compliance and health and safety compliance.  These audits may be performed on a periodic basis at times mutually agreed upon by both Parties.  The right to audit will also cover any subcontractors (e.g. a contract laboratory) if utilized by BioVectra.  Omthera also reserves the right to be present at BioVectra’s facility during the manufacture of Product.

 

9.13                        Man-In-Plant.  Omthera shall have the right, at Omthera’s expense, to put a man-in-plant at BioVectra’s facility to support BioVectra in achieving its manufacturing goals and to resolve any issues relating to the manufacture and supply of the Product that may occur during the Term.  Any such representative of Omthera will be subject to basic training on BioVectra’s quality system including safety policies and procedures and will be required to sign a waiver of liability.

 

10.                               CONFIDENTIALITY; INTELLECTUAL PROPERTY

 

10.1                        Restrictions.  Except as otherwise provided in this Section 10, during the Term of this Agreement, including any renewals thereof, and for a period of ten (10) years thereafter: (i) each Party will hold the Confidential Information of the other Party in strict confidence and will protect such Confidential Information with at least the same degree of care that it exercises with respect to its own Confidential Information, which shall be no less than a reasonable degree of care; (ii) neither Party will disclose the Confidential Information of the other without in each instance obtaining the prior written consent of the Disclosing Party; (iii) each Party will use the Confidential Information of the other only as is necessary to fulfill its obligations under this Agreement and for achieving the purposes of this Agreement and not for any other purpose; and (iv) each Party will limit internal disclosure of the other Party’s Confidential Information to its and its Affiliates’ officers, employees, consultants or agents on a need-to-know basis for purposes of fulfilling its obligations under this Agreement and achieving the purposes of this Agreement, provided, however, that each of these officers, employees, consultants and agents shall have been advised of the confidential nature of the Confidential Information, are bound by these restrictions, and have been directed to treat such information confidentially and otherwise comply with this Agreement.  In any event, the Receiving Party shall be responsible for any breach of the terms of this Agreement by any of its or its Affiliates’ officers, employees or agents.  Furthermore, Omthera may disclose Confidential Information belonging to BioVectra solely on a need-to-know-basis to its potential and existing licensors, collaborators (but not including contract manufacturers or other contract suppliers except as otherwise expressly permitted hereunder), permitted acquirers or assignees, investment bankers, investors and lenders, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use that are substantially similar to the obligations set forth in this Section 10.  The Specifications shall be treated as the Confidential Information of Omthera.

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

18

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

10.2                        Exceptions.  Notwithstanding the provisions of Section 10.1 above, neither Party shall have any obligations with respect to information which the Receiving Party can demonstrate:  (i) is or becomes generally available to the public other than through the Receiving Party’s disclosure; (ii) was in the Receiving Party’s possession prior to it being furnished by or on behalf of the Disclosing Party, provided that the Receiving Party’s source had the legal right to disclose such information; (iii) becomes available to the Receiving Party on a non-confidential basis from a source other than the Disclosing Party, provided that the Receiving Party’s source had the legal right to disclose such information; (iv) is or becomes independently developed by an employee of the Receiving Party without access to the Confidential Information and without violating any of the Receiving Party’s obligations under this Agreement; (v) is required to be disclosed to any governmental agency for purposes of obtaining patents or approvals to test or market the Product; or (vi) is required to be disclosed by order of any court of competent jurisdiction or other governmental authority, provided, however, that the Receiving Party shall provide to the Disclosing Party prompt written notice (but in no event less than fourteen (14) calendar days) prior to such disclosure so that the Disclosing Party may attempt by appropriate legal means to limit such disclosure at its cost and expense, and the Receiving Party shall endeavor in good faith to limit the disclosure and maintain the confidentiality of such Confidential Information to the maximum extent possible, provided, however, that nothing in this Agreement shall be deemed to require the Receiving Party to violate and law or judicial order.

 

10.3                        Return of Confidential Information.  Each Party agrees to promptly return all Confidential Information and all copies thereof to the Disclosing Party, and to destroy all information created by Receiving Party that contains Confidential Information furnished by Disclosing Party, at the expiration or termination of this Agreement, or at any time prior to the expiration or termination of this Agreement upon the Disclosing Party’s written request (provided, however, that the Receiving Party shall not be required to return such Confidential Information to the Disclosing Party prior to the expiration or termination or this Agreement that the Receiving Party reasonably requires in order to perform its obligations under this Agreement).  Upon request of the Disclosing Party, the Receiving Party shall provide written certification of such return or destruction.  Notwithstanding the foregoing, the Receiving Party may retain one (1) copy of such Confidential Information in its legal archive files solely for purposes of identifying such Party’s obligations under this Agreement or complying with other legal requirements, including under the Act. Notwithstanding the Receiving Party’s return and destruction of the Confidential Information, Receiving Party will continue to be bound by its obligation of confidentiality as otherwise provided herein.

 

10.4                        Omthera Intellectual Property.  All Intellectual Property, data, information, reports and any and all related documentation, which are developed, generated or derived, directly or indirectly by or on behalf Omthera prior to the Effective Date, including, Omthera Manufacturing Know-How , or any improvements, 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

19

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

modifications or enhancements thereto that are developed, generated or derived, directly or indirectly, by Omthera during the Term, will remain the sole property of Omthera.

 

10.5                        BioVectra Intellectual Property.  All Intellectual Property (including trademarks), data, information, reports, and any and all related documentation, which are developed, generated or derived, directly or indirectly by BioVectra prior to the Effective Date, including, BioVectra Manufacturing Know-How, or any improvements, modifications or enhancements thereto that are developed, generated or derived, directly or indirectly by BioVectra during the Term will remain the sole property of BioVectra.  If and to the extent that any Intellectual Property owned or controlled by BioVectra or its Affiliates  is necessary to convert Product to Finished Product, BioVectra hereby grants to Omthera and its Affiliates a worldwide, perpetual and irrevocable, paid-up, non-exclusive, limited license, with the right to sublicense through multiple tiers, to such BioVectra Intellectual Property and any other Intellectual Property owned or controlled by BioVectra, for use in connection with the sale of Finished Product from Product supplied by BioVectra hereunder.

 

10.6                        Omthera Data.  All data, images, information, documents, records in whatever form obtained, developed, recorded or compiled (i) in connection with this Agreement that relates to the Product, including, its development, manufacture or use, or (ii) based upon or utilizing Omthera Confidential Information (collectively, “Omthera Data”) are and will remain the sole and exclusive property of Omthera, and will be gathered, stored, secured, managed and maintained by BioVectra in accordance with Applicable Laws.  BioVectra agrees to take such further reasonable acts as may be requested by Omthera in order to evidence the foregoing.  After May 31, 2012, promptly upon the expiration or termination of this Agreement or otherwise upon Omthera’s request, BioVectra will promptly provide a copy of all Omthera Data to Omthera in a form acceptable to Omthera, and Omthera and its (sub)licensees will have the right to use same, and, to the extent that Omthera so requests, BioVectra will destroy all remaining originals and copies of Omthera Data in BioVectra’s possession or under BioVectra’s control, subject to regulatory requirements.  BioVectra will not utilize Omthera Data for any purpose other than the performance of its obligations under this Agreement, and will cease use of any Omthera Data after expiration or termination of this Agreement.

 

10.7                        Developed Intellectual Property.  If and to the extent any inventions, discoveries, improvements or Intellectual Property with respect to Material, Product or Finished Product comes into existence as a result of the performance of this Agreement (whether by BioVectra, Omthera or others, singly or jointly) (“Omthera Developed Intellectual Property”), such Omthera Developed Intellectual Property is hereby assigned to Omthera (and is such assignment cannot be made at present will be assigned by BioVectra and any such others to Omthera).  Omthera grants to BioVectra a worldwide, perpetual, irrevocable, paid up, non-

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

20

 

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

exclusive license, with the right to sublicenses through multiple tiers, to such Omthera Developed Intellectual Property only for non-competing purposes.

 

10.8                        Knowledge Transfer.  After May 31, 2012, BioVectra will collaborate in good faith with Omthera, Ocean Nutrition Canada, Limited and Omthera’s other qualified suppliers during the Term, including, among other things, with respect to providing reasonable access to and copies of any data applicable to the Product or Finished Products (such as batch records, internal and external lab results and the like) in BioVectra’s possession or available at no cost to BioVectra.

 

10.9                        License to BioVectra.  Subject to the terms and conditions of this Agreement, Omthera hereby grants to BioVectra a worldwide, paid-up, non-sublicenseable, non-transferable, limited (sub)license, to Intellectual Property controlled by Omthera solely to manufacture and supply Product to Omthera and its Affiliates and (sub)licensees during the Term in accordance with this Agreement, such license shall include the Intellectual Property licensed between Omthera and Ocean Nutrition Canada, Limited.  BioVectra shall have the right to review for acceptability the license between Omthera and Ocean Nutrition Canada, Limited.

 

10.10                 License to Omthera.  BioVectra hereby grants to Omthera and its Affiliates a worldwide, perpetual, irrevocable, paid up, non-exclusive license, with the right to sublicenses through multiple tiers, to such Intellectual Property owned or controlled by BioVectra that is reasonably necessary to develop, make, use, sell, distribute or commercialize Product (or any intermediate thereof), including for the conversion of Product to Finished Product; provided, however, that the foregoing license shall not be exercisable until the occurrence of the earliest to occur of the following events:

 

10.10.1       BioVectra fails to deliver Product in accordance with the Purchase Orders and warranties hereunder and such failure is not due to failure by Omthera to provide sufficient quantities of qualified Material,

 

10.10.2       BioVectra does not comply with Applicable Laws in connection with the performance of its obligations under this Agreement,

 

10.10.3       BioVectra causes any delay in Omthera’s or its (sub)licensees’ ability to obtain a Marketing Authorization anywhere in the Territory,

 

10.10.4       any early termination of this Agreement by BioVectra other than due to the material, uncured breach of this Agreement by Omthera, or

 

10.10.5       BioVectra does not supply or have the production capacity to supply the Minimum Order Quantity.

 

11.                               INDEMNIFICATION

 

11.1                        Indemnification by Omthera.  Except as otherwise specifically provided in Section

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

21

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

11.2 below, Omthera shall indemnify, defend and hold harmless BioVectra, its Affiliates, and its and their respective directors, officers, employees, agents, successors and assigns from and against any and all claims, demands, losses, damages, judgments, settlement amounts, suits, actions, liabilities, costs and expenses (including, but not limited to, court costs and reasonable attorneys’ fees) arising out of or resulting from: (i) the use of the Material in the manufacture of the Product; (ii) any negligence or willful misconduct of Omthera, its employees or agents in the use, handling (after title has passed to Omthera), shipment, distribution, marketing or sale of any Product; (iii) any injury or death to persons or theft of or damage to property resulting from the use, handling (after title has passed to Omthera), shipment, distribution, marketing or sale of any Product unless caused by non-conforming Product; (iv) the material breach by Omthera in the performance of any obligation hereunder or Omthera ‘s breach of any of its warranties or representations hereunder; (v) any labeling of any Product to the extent that such labeling has been supplied by or at the direction of Omthera and applied in accordance with instructions from Omthera; and/or (vii) any proceeding instituted by or on behalf of a Third Party based upon a claim that the manufacture by BioVectra in compliance with this Agreement (including in compliance with the Product Specifications), use or sale of the Product by Omthera infringes any intellectual property right of any Third Party including Ocean Nutrition Canada, Limited and/or (viii) Omthera’s failure to comply with Applicable Laws in the performance of its obligations under this Agreement, except in each case where such losses resulted from the negligence or willful misconduct of BioVectra.

 

11.2                        Indemnification by BioVectra.  Except as otherwise specifically provided in Section 11.1 above, BioVectra shall indemnify, defend and hold harmless Omthera, its Affiliates, and its and their respective directors, officers, employees, agents, successors and assigns from and against any and all claims, demands, losses, damages, judgments, settlement amounts, suits, actions, liabilities, costs and expenses (including, but not limited to, court costs and reasonable attorneys’ fees) arising out of or resulting from: (i) any injury or death to persons or theft of or damage to property caused directly or indirectly by non-conforming Product or by the negligence or willful misconduct of BioVectra, its employees or agents; (iii) the material breach by BioVectra in the performance of any obligation hereunder or BioVectra’s breach of any of its warranties or representations hereunder; (iii) any negligence or willful misconduct of BioVectra, its employees or agents in the manufacture, labeling, packaging, storage, or handling of Product; and/or (iv) BioVectra’s failure to comply with Applicable Laws, including, but not limited to, the Marketing Authorization pertaining to the Product, those of the Act and those relating to the environment and health and safety, except in each case where such losses resulted from the negligence or willful misconduct of Omthera.

 

11.3                        A Party (the “Indemnitee”) which intends to claim indemnification under this Section 11 shall promptly notify the other Party (the “Indemnitor”) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its Affiliates, or any of their respective directors, officers, employees or agents, or any 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

22

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Third Party entitled to indemnification under Sections 11.1 or 11.2 above, intend to claim such indemnification; provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is prejudiced by such failure.  The Indemnitee shall permit, and shall cause its Affiliates, and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such action, claim or other matter and the Indemnitee agrees to the complete control of such defense or settlement by the Indemnitor; provided that such settlement does not adversely affect the Indemnitee’s rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein in order for it to exercise such rights.  No such action, claim or other matter shall be settled without the prior written consent of the Indemnitee, and the Indemnitee shall not be responsible for any attorneys’ fees or other costs incurred other than as provided herein.  The Indemnitee, its Affiliates, and their respective directors, officers, employees and agents shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or other matter covered by this indemnification.  The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and at its own expense.

 

11.4                        Should a third party allege or claim that the manufacture, import, promotion, sale, distribution or use of the Finished Product or the manufacture, import, promotion, sale, distribution or use of a medicinal product containing the Finished Product infringes a third party’s patent or other intellectual property rights, BioVectra shall reasonably support Omthera in its defense against such claim.

 

11.5                        Should a third party allege or claim that the manufacture, import, promotion, sale, distribution or use of the Product infringes a third party’s patent or other intellectual property rights, at Omthera’s request, the Parties shall collaborate to develop a strategy to deal with the third party’s claim which may include a non-infringing manufacturing alternative.  If such claim results in a judgment or settlement against Omthera and Omthera abandoned the sale, or commercialization of Finished Product then Omthera may terminate this Agreement, at its option, upon ninety (90) days advance written notice.   Upon receipt of notice of termination from Omthera pursuant to this provision, BioVectra will immediately plan for a shutdown of all activities relating to the Product and will take reasonable steps to eliminate unnecessary expenditures.  Omthera shall be responsible for all reasonable expenses incurred by BioVectra as a result of the termination of the contract including amounts for the Minimum Order Quantities up to the point of termination hereunder, amounts for Product manufactured pursuant to an existing Purchase Order, amounts for work in progress, materials and supplies inventory (to the extent the costs can’t be recovered through returns/resale), reasonable wind-down expenses (including employee termination expenses), non-cancelable commitments, together with the cost of the removal of equipment as set out in Section 2.6 herein.  BioVectra shall invoice Omthera for all such expenses incurred under this Section 11.5, along with supporting documentation for such 

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

23

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

expenses, within sixty (60) days of the termination date.  Omthera shall pay such amounts within thirty (30) days of receipt of a proper invoice and conforming documentation.  Thereafter, Omthera shall have no further payment obligation to BioVectra.

 

12.                               LIMITATIONS ON LIABILITY

 

12.1                        In no event shall either Party be liable to the other Party for any indirect, incidental, special, consequential, punitive or exemplary damages (including, but not limited to, damages based upon lost profits, business interruption, lost business, or lost savings) for any acts or failure to act under this Agreement, even if it has been advised of their possible existence, except as a consequence of failure of Omthera to purchase the Minimum Order Quantity.  Notwithstanding the foregoing, there shall be no limitation on a Party’s liability for claims: a) arising out of a breach of its confidentiality obligations under this Agreement; or b) arising out of its indemnification obligations under this Agreement.

 

12.2                        Unless otherwise specified herein including in Sections 2.5 (Termination of Construction), 3.3 (Termination by Omthera for Commercialization Issues) and 11.5 the total aggregate amount that a Party shall be liable for and required to pay to a third party in respect of losses, damages, claims, costs or expenses (collectively “Losses”) that are asserted against or suffered by the other Party arising out of, in connection with or based upon the breach or failure to perform the provisions of this Agreement shall not exceed [...***...].  Notwithstanding the foregoing, there shall be no limitation on a Party’s liability for claims: a) arising out of a breach of its confidentiality obligations under this Agreement; or b) arising out of its indemnification obligations under this Agreement. Furthermore, the foregoing shall not be applied to limit Omthera’s right to seek specific performance from BioVectra hereunder and thereby require BioVectra to perform its obligations hereunder.  Nothing in this Agreement shall exclude or limit the liability of either Party for death or personal injury caused by its negligence.

 

13.                               INSURANCE

 

Each Party shall obtain and maintain at its expense during the term of this Agreement and for a period of [...***...] after the expiration or termination of this Agreement, all insurance coverage required by law as well as appropriate insurance coverage to protect against any and all claims or liabilities that may arise directly or indirectly as a result of its performance under this Agreement.  In this regard, each Party shall maintain at least[...***...] of product liability insurance for the duration of this Agreement and [...***...].

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

24

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

14.                               MISCELLANEOUS

 

14.1                        Independent Contractors.  The relationship between Omthera and BioVectra is that of independent contractors and nothing contained in this Agreement shall be deemed to constitute or create any other relationship, including employment, partnership, agency or joint venture, between Omthera and BioVectra. Neither Party shall have any express or implied right or authority to employ any person as agent or employee for or on behalf of the other, or to bind or attempt to bind the other Party to any obligation with any Third Party.

 

14.2                        Assignment and Subcontracting.  Neither Party shall assign any of its rights nor delegate or subcontract any of its duties under this Agreement without the prior written consent of the other Party; provided, however, that a Party may assign this Agreement (a) to an Affiliate; or (b) in connection with the sale of all or substantially all of the assets or business to which this Agreement relates (whether by sale, merger, reorganization, consolidation or otherwise). Any such attempted assignment of rights or delegation or subcontracting of duties without complying with the foregoing shall be void and ineffective. Any such delegation or subcontracting consented to by shall not relieve the Party of its responsibilities and liabilities hereunder, and the delegating or subcontracting Party shall remain liable to the other Party for the conduct and performance of each permitted delegate and subcontractor hereunder.

 

14.3                        Advertising and Publicity.  BioVectra shall not use the name or any trademark, trade name, logo or symbol of Omthera or any Omthera Affiliates, or disclose any matters relating to this Agreement, in any advertising, promotion, press/publicity release, written articles or other form of public written disclosure without the prior written consent of Omthera. Omthera shall not disclose and matters relating to this Agreement nor issue any press/publicity release referring to BioVectra without the prior written permission of BioVectra, which shall not be unreasonably withheld,  conditioned or delayed.  It is understood by BioVectra that Omthera, as the holder of the Product Marketing Authorization, will have to make certain disclosures and regulatory filings indicating that BioVectra is manufacturing the Product for Omthera.

 

14.4                        Force Majeure.  Neither Party shall be liable for delays in performance or nonperformance in whole or in part due to any causes that are beyond its reasonable control and not due to its acts or omissions, such as acts of God, fire, strikes,  embargo, war, acts of terrorism, acts of the government, or any other similar causes, but not acts which could be anticipated, such as raw material price increases, shortages of raw materials, or an increase in demand for Product.  In such event, the Party delayed shall promptly give notice to the other Party, and shall endeavor in good faith to eliminate, cure or overcome any such causes and to resume performance of its obligations as soon as possible.  The Party affected by the other Party’s delay may elect to:  (a) suspend performance and extend the time for performance for the duration of the event, or (b) cancel all or part of any part of

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

25

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

the unperformed part of this Agreement or any individual Purchase Order(s) hereunder.

 

14.5                        Notices.  Any notice, communication, or statement required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given when delivered to the person(s) listed below in any of the following manners: (i) in person; (ii) by registered or certified mail, postage pre-paid, return receipt requested; (iii) by a nationally-recognized courier service guaranteeing next-day delivery, charges prepaid; or (iv) by facsimile with the original promptly sent by any of the foregoing manners.  Notice or receipt of a particular communication shall be considered given or received when actually received. Either Party may, by notice to the other, change the names and addresses given below for receipt of notices.

 

If to BioVectra:

 

BioVectra Inc.

Attn:       Chief Executive Officer

11 Aviation Avenue

Charlottetown, Prince Edward Island

C1E0A1 Canada

Facsimile No.:  (902) 566-2498

With a copy to:

BioVectra Inc.

Attn:       Legal Department

11 Aviation Avenue

Charlottetown, Prince Edward Island

C1E0A1 Canada

Facsimile No.:  (902) 566-2498

If to Omthera:

Omthera Pharmaceuticals, Inc.

Attn: Chief Executive Officer

707 State Road

Princeton, NJ

08540, USA

Facsimile No.

 

With a copy to:      Omthera Legal

Omthera Pharmaceuticals, Inc.

707 State Road

Princeton, NJ

08540, USA

Facsimile No.

 

14.6                        Non-Waiver.  The failure of either Party to strictly enforce any of the terms or conditions of this Agreement shall not be considered as a waiver of any right

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

26

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

hereunder nor shall it deprive that Party of the right at some other time to insist upon strict adherence to that term or condition or to any other terms or conditions.

 

14.7                        Severability.  If any section, subsection, sentence or clause of this Agreement shall be adjudged illegal, invalid or unenforceable, such illegality, invalidity or unenforceability shall not affect the legality, validity or enforceability of this Agreement as a whole or of any section, subsection, sentence or clause hereof not so adjudged, and the remaining terms and provisions of this Agreement shall remain unimpaired and in full force and effect.

 

14.8                        Paragraph Headings.  All paragraph headings in this Agreement are for convenience of reference only and shall not be construed as a limitation of the scope of the particular sections to which they refer.

 

14.9                        Governing Law and Arbitration.  This Agreement will be governed by the laws of the State of New York, without regard to its, or any other jurisdictions, conflicts of laws provisions or rulings.  Any dispute, claim or controversy that may arise under, out of, in connection with or relating to this Agreement or any breach or default in the performance of the terms and conditions thereof, which cannot be settled by the Parties, shall be settled by final and binding arbitration in the English language in New York, New York, U.S.A. in accordance with the then-existing Rules of Commercial Arbitration (the “Rules”) promulgated by the American Arbitration Association (the “AAA”). The arbitrator(s) shall apply the governing law as set forth above in this Section 14.9 and judgment upon the award of the arbitrator(s) may be entered in any court having appropriate jurisdiction.

 

14.10                 Successors and Assigns.  This Agreement shall apply to, inure to the benefit of and be binding upon the Parties hereto and upon their respective successors and permitted assigns.  The Parties agree that this Agreement is not intended by either Party to give any benefits, rights, privileges, actions or remedies to any person, partnership, firm or corporation as a third party beneficiary or otherwise under any theory of law, except as expressly set forth herein.

 

14.11                 Schedules.  All schedules referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

 

14.12                 Review by Legal Counsel.  Each of the Parties agrees that it has had the opportunity to review this Agreement with its legal counsel.  Accordingly, the rule of construction that any ambiguity in this Agreement is to be construed against the drafting Party shall not apply.

 

14.13                 Amendments.  No modification, alteration or amendment of this Agreement or any Purchase Order(s) hereunder shall be binding upon the Parties unless contained in a writing signed and delivered by a duly authorized representative of each respective Party and specifically referring hereto or thereto, as the case may be.

 

14.14                 Counterparts.  This Agreement and any amendment or supplement hereto may be

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

27

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

executed in any number of counterparts, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument.  The execution of this Agreement and any such amendment or supplement by any Party hereto will not become effective until counterparts hereof have been executed (i.e., signed and delivered) by both Parties hereto.

 

14.15                 Entire Agreement.  This Agreement, together with any documents attached hereto, constitutes the entire agreement of the Parties with respect to its subject matter and merges and supersedes all prior discussions and writings with respect thereto.  No modification to this Agreement shall be affected by the acknowledgment or acceptance of any purchase order or shipping instruction forms or similar documents containing terms or conditions at variance with or in addition to those set forth herein.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized representatives to be effective as of the Effective Date set forth above.

 

 

	
OMTHERA PHARMACEUTICALS, INC.
    	
BIOVECTRA INC.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Signature:
    	
/s/Dr. Ben   Machielse
    	
 
    	
Signature:
    	
/s/Dale   W. Zajicek
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Dr. Ben   Machielse
    	
 
    	
Name:
    	
Dale   W. Zajicek
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
EVP &   COO
    	
 
    	
Title:
    	
President
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
03/27/2012
    	
 
    	
Date:
    	
March 27,   2012
    

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

28

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

SCHEDULE 1

 

To the Supply Agreement between Omthera and BioVectra.

 

SPECIFICATIONS

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

29

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

30

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

31

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

32

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

33

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

SCHEDULE 2

 

To the Supply Agreement between Omthera and BioVectra.

 

OMTHERA OWNED EQUIPMENT

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

34

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

SCHEDULE 3

 

To the Supply Agreement between Omthera and BioVectra.

 

PRICE

 

Price:

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

35

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

[...***...]

 

	
***Confidential Treatment   Requested
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Omthera
    	
 
    	
BioVectra
    

 

36Exhibit 10.6

 

EXECUTION VERSION

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

 

Intermediate Feedstock 
 Supply Agreement

 

 

Date:

12 March 2012

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Table of Contents

 

	
TABLE OF CONTENTS
    	
II
    
	
 
    	
 
    
	
ARTICLE ONE. INTERPRETATION
    	
1
    
	
 
    	
 
    
	
1.01
    	
DEFINITIONS:
    	
1
    
	
1.02
    	
INTERPRETATION   AND CONSTRUCTION:
    	
8
    
	
1.03
    	
SCHEDULES:
    	
10
    
	
1.04
    	
CALCULATION   OF TIME:
    	
10
    
	
 
    	
 
    	
 
    
	
ARTICLE TWO. SUPPLY OF FEEDSTOCK
    	
10
    
	
 
    	
 
    
	
2.01
    	
SUPPLY:
    	
10
    
	
2.02
    	
PRICE:
    	
10
    
	
2.03
    	
INCENTIVE   PAYMENT:
    	
16
    
	
2.04
    	
FORECASTING:
    	
16
    
	
2.05
    	
ORDERS:
    	
18
    
	
2.06
    	
SHIPMENT:
    	
19
    
	
2.07
    	
DELIVERY:
    	
19
    
	
2.08
    	
SHELF   LIFE:
    	
19
    
	
2.09
    	
ACCEPTANCE   OF THE FEEDSTOCK:
    	
19
    
	
2.10
    	
INCOMPLETE   DELIVERY:
    	
21
    
	
2.11
    	
SAFETY   STOCK:
    	
21
    
	
2.12
    	
CERTIFICATE   OF ANALYSIS; MATERIAL SAFETY DATA SHEET:
    	
22
    
	
2.13
    	
PAYMENT:
    	
22
    
	
2.14
    	
EXCLUSIVITY:
    	
22
    
	
2.15
    	
REGULATORY   COMPLIANCE:
    	
23
    
	
2.16
    	
REPRESENTATIONS   AND WARRANTIES:
    	
27
    
	
2.17
    	
INDEMNIFICATION:
    	
29
    
	
2.18
    	
RECALLS   AND TRACEABILITY:
    	
31
    
	
 
    	
 
    	
 
    
	
ARTICLE THREE. TERM AND TERMINATION
    	
32
    
	
 
    	
 
    
	
3.01
    	
TERM:
    	
32
    
	
3.02
    	
TERMINATION:
    	
32
    
	
3.03
    	
EFFECT   OF TERMINATION OR EXPIRATION:
    	
34
    
	
 
    	
 
    	
 
    
	
ARTICLE FOUR. CONFIDENTIALITY;   LICENSEES; INTELLECTUAL PROPERTY
    	
35
    
	
 
    	
 
    
	
4.01
    	
DISCLOSURE:   STANDARD OF CARE:
    	
35
    
	
4.02
    	
COMPELLED   DISCLOSURE:
    	
36
    
	
4.03
    	
REGULATORY   DISCLOSURES:
    	
36
    
	
4.04
    	
LICENSEES:
    	
36
    
	
4.05
    	
INTELLECTUAL   PROPERTY:
    	
36
    
	
4.06
    	
KNOWLEDGE   TRANSFER:
    	
38
    
	
 
    	
 
    	
 
    
	
ARTICLE FIVE. GENERAL
    	
39
    
	
 
    	
 
    
	
5.01
    	
CONDITION   PRECEDENT:
    	
39
    
	
5.02
    	
INSURANCE:
    	
40
    
	
5.03
    	
LIMITATION   OF LIABILITY:
    	
40
    
	
5.04
    	
PUBLICITY:
    	
40
    
	
5.05
    	
ENTIRE   AGREEMENT:
    	
40
    
	
5.06
    	
GOVERNING   LAW:
    	
41
    
	
5.07
    	
FORCE   MAJEURE:
    	
41
    
	
5.08
    	
SEVERABILITY:
    	
41
    

 

***Confidential Treatment Requested

 

ii

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

	
5.09
    	
FURTHER   ASSURANCES:
    	
41
    
	
5.10
    	
NO   AMENDMENTS:
    	
42
    
	
5.11
    	
NO   ASSIGNMENT:
    	
42
    
	
5.12
    	
NO   WAIVER:
    	
42
    
	
5.13
    	
NO   AGENCY:
    	
42
    
	
5.14
    	
NOTICES:
    	
42
    
	
5.15
    	
COUNTERPARTS:
    	
43
    
	
 
    	
 
    	
 
    
	
SCHEDULE “A” — SPECIFICATIONS FOR THE   FEEDSTOCK
    	
1
    
	
 
    	
 
    
	
SCHEDULE “B” — SUPPLY PRICE VARIABILITY   RELATED TO COST OF CRUDE FISH OIL
    	
1
    
	
 
    	
 
    
	
SCHEDULE “C” - CURRENT LAUNCH PLANS
    	
1
    
	
 
    	
 
    
	
SCHEDULE “D” - PRODUCTION STANDARDS
    	
1
    
	
 
    	
 
    
	
SCHEDULE “E” - INCOMING FISH OIL   SPECIFICATIONS
    	
1
    

 

***Confidential Treatment Requested

 

iii

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

This Intermediate Feedstock Supply Agreement (the “Agreement”) made this 12th day of March, 2012(the “Effective Date”)

 

BETWEEN:

 

Ocean Nutrition Canada Limited, a body corporate constituted under the laws of Canada (“ONC”)

 

-and-

 

Omthera Pharmaceuticals Inc., a body corporate constituted under the laws of Delaware (“Omthera”)

 

(Individually, a “Party” and collectively, the “Parties”)

 

RECITES:

 

A.                                    ONC is in the business of manufacturing, processing and supplying marine-derived Omega-3 oils;

 

B.                                    Omthera is in the business of manufacturing, processing and supplying and commercializing active pharmaceutical ingredients and, in particular, the drug Epanova and products containing the active pharmaceutical ingredient Omefas;

 

C.                                    Omthera desires to purchase from ONC certain products and ONC desires to sell such products to Omthera on the terms set out herein;

 

NOW THEREFORE in consideration of the mutual promises and covenants herein, and other good and valuable consideration, the sufficiency of which is acknowledged by the Parties, the Parties agree as follows:

 

Article One. Interpretation

 

1.01                        Definitions:

 

In this Agreement,

 

(a)                                 “Act” has the meaning assigned in Section 2.16(e);

 

(b)                                 “Affiliate” means, with respect to any entity, any other entity that directly or indirectly Controls, is Controlled by, or is under common Control with, such entity;

 

(c)                                  “Applicable Laws” means all relevant federal, provincial, state and local laws, statutes, rules, regulations, requirements, and ordinances and industry standards and guidelines as in effect on the Effective Date or adopted 

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

thereafter and which are applicable to a Party’s activities hereunder, including the applicable regulations and guidelines of any Relevant Regulatory Authority, including the FDA and other competent authorities and all applicable cGMPs, together with amendments thereto;

 

(d)                                 “Business Day” means a day, other than a Saturday or a Sunday or statutory holiday, on which both (i) the main commercial branch of the Bank of Nova Scotia in the City of Halifax, Nova Scotia, is open for business to general retail clients, and (ii) the main commercial branch of the largest retail bank (based on assets) in the City of New York, New York, is open for business to general retail clients;

 

(e)                                  “Calendar Year” means that interval of time from January 1 to December 31;

 

(f)                                   “Capacity Forecast” has the meaning assigned in Section 2.04(3);

 

(g)                                  “Certificate of Analysis” means a document which is signed and dated by a duly authorised representative of ONC certifying that a specific batch of the Feedstock conforms with the Specifications and which includes relevant analytical information mutually-agreed upon;

 

(h)                                 “Certificate of Origin” means a document which is signed and dated by a duly authorized representative of ONC certifying that a specific batch of the Feedstock is manufactured using Incoming Fish Oil meeting the Incoming Fish Oil Specifications;

 

(i)                                     “Certificate of Compliance” means a document which is signed and dated by a duly authorized quality assurance representative of ONC certifying that the specific batch of the Feedstock has been manufactured meeting all applicable cGMP regulations;

 

(j)                                    “cGMP” means current good manufacturing practice and standards as provided for (and as amended from time to time) in the Current Good Manufacturing Practice Regulations to the US Code of Federal Regulations Title 21 (21 CFR 210 and 21 CFR 211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7 and subject to any arrangements, additions or clarifications agreed from time to time between the Parties in the Quality Technical Agreement;

 

(k)                                 “Confidential Information” means: (a) any information relating to the product plans, specifications, designs, costs,

 

***Confidential Treatment Requested

 

2

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

prices and names, finances, marketing plans, business opportunities, personnel, research, development, or Intellectual Property Rights of a Party, regardless of when such information was revealed or disclosed; (b) any information that is disclosed by the Disclosing Party and which would reasonably be considered to be confidential or proprietary information, which specifically includes any materials that are marked as being confidential; and (c) the terms and conditions of this Agreement (which terms and conditions will be treated as the Confidential Information of both Parties); provided, however, that “Confidential Information” shall not include information that: (i) was generally available to the public at the time of receipt from the Disclosing Party, or thereafter becomes generally available to the public other than through a breach of this Agreement by the Receiving Party; (ii) is known to the Receiving Party on a non-confidential basis prior to its receipt from the Disclosing Party and such knowledge can be proven; (iii) is disclosed with the prior written consent of the Disclosing Party; (iv) becomes known to the Receiving Party from a source other than the Disclosing Party without breach of this Agreement by the Receiving Party; (v) was required to be disclosed pursuant to law; or (vi) was developed independently by personnel of the Receiving Party who had no substantive knowledge of the Disclosing Party’s Confidential Information at the time of such independent development;

 

(l)                                     “Control” means, with respect to a party, the power to direct or cause the direction of the management or policies of a party, whether through the ownership of voting securities, by contract, resolution, regulation or otherwise;

 

(m)                             “Crude Fish Oil” has the meaning assigned in Section 4.01;

 

(n)                                 “Delivery Note” means a document specifying the Feedstock by SKU, description, ONC batch number, Feedstock expiry date, total quantity, quantity by packaging unit and other details reasonably required and requested by Omthera from time to time;

 

(o)                                 “Disclosing Party” has the meaning assigned in Section 4.01;

 

(p)                                 “Effective Date” means the date inscribed at the top of the first page of this Agreement;

 

(q)                                 “FDA” means United States Food and Drug Administration or any successor entity thereto;

 

(r)                                    “Feedstock” means those certain fish derived Omega-3 oils, the Specifications for which are set out in Schedule “A”;

 

***Confidential Treatment Requested

 

3

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(s)                                   “Finished Product” means any product produced by Omthera, a Licensee or an ultimate customer of Omthera that incorporates or includes Feedstock or other fish-oil intermediates as an ingredient or an intermediary, including Epanova and Omefas;

 

(t)                                    “First Year” has the meaning assigned in Section 2.04(2)(a);

 

(u)                                 “FO Order” has the meaning assigned in Section 2.04(2)(c);

 

(v)                                 “Force Majeure Event” has the meaning assigned in Section 5.07;

 

(w)                               “FX Order” has the meaning assigned in Section 2.04(2)(a);

 

(x)                                 “Incoming Fish Oil” means the raw, and pre treated fish oil of the type actually used for processing into Feedstock;

 

(y)                                 “Incoming Fish Oil Specifications” has the meaning assigned in Section 4.01;

 

(z)                                  “Information” will mean all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether or not patentable), methods, manufacturing processes, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions and software, (b) compounds, compositions of matter, cells, cell lines, assays, and physical, biological or chemical material, and (c) marketing data, including clinical studies designed to support promotional efforts, all of which relate to any Finished Product or any fish-oil intermediates (including Feedstock) in any indication;

 

(aa)                          “Intellectual Property Right” means any and all patents, patent applications, all provisional, divisional, continuations, renewals, continuations-in-part, re-examinations, patents of addition, supplementary protection certificates, extensions, letters of patent, registration or confirmation patents and reissues with respect to any patents described in this paragraph, any Know-How, data, technology, inventions, copyrights, industrial property and technical information, and any and all rights in or to any of the foregoing;

 

(bb)                          “Know-How” means all non-patented proprietary information, inventions, discoveries, designs, developments, techniques, materials, processes, manufactures, compositions of matter or methods of use and trade secrets, whether or not patentable or copyrightable;

 

(cc)                            “Latent Defect” means a defect which existed in the Feedstock at the time of delivery by ONC to the shipping 

 

***Confidential Treatment Requested

 

4

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

destination; which did not exist at the start of the ONC manufacturing process (provided ONC complied with Section 2.16(a) through 2.16(e)); which was not reasonably discoverable upon visual inspection or testing (as defined in the Specifications) and negatively affects the safety or efficacy of the Feedstock or the Finished Product (including compliance with cGMP). Any defects caused by variability in the Incoming Fish Oil (provided the Incoming Fish Oil satisfied the Incoming Fish Oil Specifications) are excluded from this definition;

 

(dd)                          “Licensee” means any person or entity to whom Omthera has granted the right to develop, manufacture, sell, distribute or commercialize the Finished Product, which includes, as of the Effective Date hereof, or will include BioVectra Inc. and Croda International plc;

 

(ee)                            “Losses” has the meaning assigned in Section 2.04(2)(a);

 

(ff)                              “Marketing Authorisation” in relation to a Finished Product, is the grant of all necessary registrations, listings, approvals or licences by the Relevant Regulatory Authority in the Territory for the importation, storage, promotion, sale or distribution of that Finished Product;

 

(gg)                            “Material Regulatory Risk” has the meaning assigned in Section 2.15(5)(a);

 

(hh)                          “Notice Period” has the meaning assigned in Section 2.04(2)(a);

 

(ii)                                  “Omefas” means an omega-3 FFA concentrate used as sole active pharmaceutical ingredient for the drug “Epanova”;

 

(jj)                                “Omthera Data” has the meaning assigned in Section 4.05(7);

 

(kk)                          “Omthera Manufacturing Know-How” will mean all data, Information and Know-How owned or controlled by Omthera or its Affiliates, licensors, Licensees or other collaborators (other than ONC) prior to the Effective Date or developed or acquired by or for Omthera or its Affiliates, licensors, Licensees or other collaborators thereafter and relating to the manufacturing, processing, formulating, packaging, labelling, holding and quality control testing of any Finished Product or any fish-oil intermediates (including Feedstock);

 

(ll)                                  “ONC Intellectual Property” has the meaning assigned in Section 2.04(2)(b);

 

(mm)                  “ONC Manufacturing Know-How” will mean all data, Information and Know-How owned or controlled by ONC or any of its Affiliates prior to the Effective Date or developed or 

 

***Confidential Treatment Requested

 

5

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

acquired by or for ONC or any of its Affiliates thereafter and relating to the manufacturing, processing, formulating, packaging, labelling, holding and quality control testing of any Finished Product or any fish-oil intermediates (including the Feedstock);

 

(nn)                          “PL Order” has the meaning assigned in Section 2.04(2)(b);

 

(oo)                          “Production Standards” means those manufacturing and production standards and quality controls as set out at Schedule “D”, as may be amended by the Parties from time to time;

 

(pp)                          “Quality Technical Agreement” (or “QTA”) has the meaning assigned in Section 2.02(4);

 

(qq)                          “Receiving Party” has the meaning assigned in Section 4.01;

 

(rr)                                “Regulatory Recall” has the meaning assigned in Section 2.18;

 

(ss)                              “Relevant Regulatory Authority” in relation to a country or region, means the governmental authority, whether federal, state, provincial, or municipal, regulating the use, importation, manufacture, marketing, sale or distribution of pharmaceutical substances and the grant of Marketing Authorisations in such country or region;

 

(tt)                                “Shelf Life” means the period of time during which Feedstock may be stored and remain suitable for use, which will be a minimum of [...***...] and may be extended based on stability studies demonstrating longer shelf life;

 

(uu)                          “Specifications” means the specifications for the Feedstock, which are attached as Schedule “A”;

 

(vv)                          “Supply Price” has the meaning assigned in Section 2.02(1);

 

(ww)                      “Supply Problem” has the meaning assigned in Section 2.02(1);

 

(xx)                          “Term” has the meaning assigned in Section 3.01;

 

(yy)                          “Territory” means worldwide; and

 

(zz)                            “Test Samples” has the meaning assigned in Section 2.06.

 

1.02                        Interpretation and Construction:

 

In this Agreement, unless the context otherwise requires:

 

(a)                                 any use of the word “including” shall be deemed and interpreted to mean “including without limitation”;

 

(b)                                 any use of the masculine, feminine or neuter case shall be interpreted to include the other cases as may be required;

 

***Confidential Treatment Requested

 

6

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(c)                                  any use of the singular or plural shall be interpreted to include the other case as may be required;

 

(d)                                 a reference to a clause or a Schedule is to a clause or Schedule of this Agreement, and a reference in a Schedule to a clause is a reference to a clause in that Schedule;

 

(e)                                  a reference to any monetary amount is to lawful currency of the United States of America;

 

(f)                                   words or phrases appearing in this Agreement with capitalised initial letters are defined terms and have the meanings given to them in this Agreement;

 

(g)                                  a reference to any document, including this Agreement, includes a reference to that document as amended or replaced from time to time;

 

(h)                                 headings appear as a matter of convenience and do not affect the construction of this Agreement;

 

(i)                                     a reference to a prohibition against doing anything includes a reference to not permitting, suffering or causing that thing to be done;

 

(j)                                    the rule of construction known as the contra proferentem rule does not apply to this Agreement;

 

(k)                                 a reference to a Party to this Agreement or any other document includes that Party’s personal representatives, successors and permitted assigns;

 

(l)                                     a reference to a person includes a corporation and also a body of persons, whether corporate or unincorporated;

 

(m)                             where a word or expression is defined in this Agreement, other parts of speech and grammatical forms of that word or expression have corresponding meanings;

 

(n)                                 a reference to a statute or any regulations is a reference to that statute or those regulations as amended, or to any statute or regulations substituted for that statute or those regulations; and

 

(o)                                 a reference to “written” or “in writing” includes all modes of presenting or reproducing words, figures and symbols in a tangible and permanently visible form.

 

1.03                        Schedules:

 

This Agreement contains the following schedules, each of which shall be deemed to be an integral part of this Agreement:

 

(a)                                 The Specifications;

 

(b)                                 Supply Price Variability related to Cost of Crude Fish Oil;

 

(c)                                  Current Launch Plans;

 

(d)                                 Production Standards; and

 

***Confidential Treatment Requested

 

7

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(e)                                  Incoming Fish Oil (crude fish oil) specifications (the “Incoming Fish Oil Specifications”)

 

1.04                        Calculation of Time:

 

When calculating the period of time within which or following which any act is to be done or step taken pursuant to this Agreement, the date which is the reference day in calculating such period shall be excluded. Any payment or action to be made or taken on a day other than a Business Day shall be made or taken on the immediately following day that is a Business Day. Any reference to a particular time in this Agreement shall refer to the time zone applicable in Halifax, Nova Scotia.

 

Article Two. Supply of Feedstock

 

2.01                        Supply:

 

During the Term, ONC shall supply Feedstock to Omthera and its Licensees based on FX Orders placed by Omthera and forecasts provided by Omthera in accordance with Section 2.03.

 

2.02                        Price:

 

(1)                                 Initial Price:

 

The supply price for Feedstock (the “Supply Price”) shall be determined by the quantity of Feedstock to be purchased in a particular Calendar Year, as set out below and as adjusted in accordance with Section 2.02(2):

 

(a)                                 [...***...]

 

(b)                                 [...***...]

 

(c)                                  [...***...]

 

(d)                                 [...***...]

 

All pricing set out herein is Ex Works ONC’s facility designated by ONC in its acknowledgement of each FX Order.

 

(2)                                 Price adjustment:

 

The Supply Price is based on assumptions related to the cost of Crude Fish Oil and inflation existing at the time of execution of the Agreement and is subject to adjustment as provided for in this Section 2.02(2).

 

(a)                                 Adjustment for Cost of Crude Fish Oil:

 

The Supply Price for the Feedstock shall vary according to changes in the price of “Crude Fish Oil”, using [...***...]  crude fish oil as a reasonable proxy to indicate increase and decreases in the market price of fish oil. Sixty (60) days following [...***...], ONC shall calculate the weighted average export price for [...***...] Crude Fish Oil based on information published by [...***...]  and shall adjust the Supply Price to directly reflect the increase or decrease of the cost of Crude Fish Oil as illustrated in Schedule “B”. ONC will provide Omthera with copies of such information as published by [...***...]. For the purposes of this

 

***Confidential Treatment Requested

 

8

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

adjustment, the baseline cost of Crude Fish Oil as of the Effective Date is [...***...]. ONC shall source Incoming Fish Oil from [...***...], and in the event of any Force Majeure Event that requires ONC to source Incoming Fish Oil from any fishery other than [...***...], ONC will first seek to source Incoming Fish Oil from the fisheries in [...***...], and if a fishery outside those areas is required to be used based on a Force Majeure Event, the Parties will cooperate to qualify such new source of Incoming Fish Oil, and the actual acquisition cost of Incoming Fish Oil shall be used if no general information like that provided by the [...***...] described above is available for the fishery used. ONC will provide Omthera with all reasonable supporting documentation, and Omthera will have the right to have the calculation of any such price adjustment verified by an independent expert at Omthera’s cost. At either Party’s request, the Parties shall qualify additional fisheries.

 

(b)                                 Adjustment for CCPI

 

ONC has provided pricing over the Term based on the assumption that its variable costs associated with labour, transportation, duties/taxes, utilities and raw materials directly related to the manufacturing process (other than Crude Fish Oil) will remain stable. ONC shall have the right to increase the prices charged for the Feedstock pursuant to Section 2.02(1) [...***...]  after the Effective Date [...***...]  to reflect any increases in the Canadian Consumer Price Index published by Statistics Canada for [...***...].

 

(3)                                 Adjustment of Specifications

 

(a)                                 In the event that any change in the Specifications necessitated by a mandatory change in regulations imposed by a Relevant Regulatory Authority in order to maintain the Marketing Authorisation for a Finished Product increases or decreases ONC’s costs related to the production of Feedstock, the Supply Price shall be adjusted accordingly so that such incremental increase or decrease in cost is directly reflected in the relevant price, provided that only the relevant portion of such costs directly and specifically applicable to production of Feedstock will be included in such adjustment. In the event of any change in regulations after the Effective Date that may require a capital outlay specific to the change by ONC in order that the Feedstock complies with such regulation, the Supply Price shall be adjusted so that ONC recovers all of its capital outlay[...***...], provided that  [...***...]. In any such case, before incurring any such costs or making such capital

 

***Confidential Treatment Requested

 

9

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

outlay, the Parties shall meet and discuss. For clarity, by “directly and specifically” as used above it is understood that [...***...].  Any change in Specifications required under this Section 2.02(3)(a) must be agreed-upon by ONC and ONC shall have the option to terminate this Agreement in the event that it concludes it is not able to supply Feedstock that complies with a proposed new Specifications or is unwilling to make the requisite capital expenditure based in the change in Specifications (in the event that Omthera does not elect to pay all such expenditure), provided that the Parties will meet to discuss any such new proposed Specifications and ONC will use reasonable efforts to meet such proposed new Specifications taking into account any costs Omthera may pay as stated above.

 

(b)                                 In the event that a change is required in the Specifications, Incoming Fish Oil Specifications or Production Standards as requested by Omthera, then ONC shall promptly and in good faith consider such changes and shall advise Omthera of any changes in the Supply Price (subject to Section 2.02) that would apply if such changes were implemented. If required by Omthera, the Parties shall cooperate in good faith to promptly implement the changes on terms as the Parties agree in writing.

 

(c)                                  Omthera will, to the extent that it is able to do so, keep ONC apprised of any anticipated or proposed changes to Production Standards or other regulatory matters or consultations or requests for comments being carried out with Relevant Regulatory Authorities that may have an effect on ONC and the Feedstock supplied hereunder.

 

(4)                                 Quality and Technical Standards

 

ONC will perform its obligations under this Agreement in accordance with the terms and conditions of this Agreement and the Quality Technical Agreement and in compliance with cGMPs, all Applicable Laws, Marketing Authorisations, the Specifications, and any reasonable written instructions provided by Omthera as agreed by ONC. All Feedstock will be produced, manufactured, packaged,

 

***Confidential Treatment Requested

 

10

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

labeled and shipped in accordance with this Agreement, cGMPs, Applicable Laws and the instructions of Omthera. When required ONC will develop QTA’s with the other contract manufacturers to define the Quality, Technical and cGMP responsibilities. Omthera will have the right to approve these QTAs, acting reasonably. The Parties shall enter into the “Quality Technical Agreement” [...***...]. ONC will take such steps as are reasonably required to become a qualified supplier of each of the Licensees.

 

(5)                                 Site Approvals

 

ONC acknowledges that any site used in the manufacture of Feedstock shall be subject to verification that such site complies with the Production Standards. ONC shall not utilize alternative sites for production and supply of Feedstock for Omthera unless such sites have been verified with respect to Production Standards compliance. Any site approval under this Section shall not relieve ONC of its ongoing obligation to comply with Production Standards at such site for the production and supply of Feedstock under this Agreement. Before seeking to qualify any other sites, ONC will first seek Omthera’s prior written consent, not to be unreasonably withheld, and in qualifying any such other site, the Parties will discuss any Supply Price improvements that may be shared between the Parties based on the involvement of the new site in supplying Feedstock.

 

(6)                                 Notice of Non-Conformity

 

ONC shall immediately notify Omthera in writing if ONC becomes aware that any Feedstock or Incoming Fish Oil used in the production of such Feedstock delivered or to be delivered does not, or likely does not, conform to the requirements of the Relevant Regulatory Authorities, the Specifications, Incoming Fish Oil Specifications, Production Standards and other quality and technical standards as agreed by the Parties under this Agreement.

 

2.03                        [...***...]:

 

Omthera will forthwith pay ONC  [...***...] upon [...***...].

 

Omthera will forthwith pay ONC [...***...] upon [...***...].

 

2.04                        Forecasting:

 

(1)                                 Preliminary forecast:

 

Within [...***...], Omthera shall provide ONC with a non-binding, good faith estimate of its estimated requirements of Feedstock for [...***...]. Omthera shall keep ONC reasonably apprised of any significant developments or milestones that would have any effect on the timing of demand, such as any applications made to relevant regulatory authorities for

 

***Confidential Treatment Requested

 

11

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Marketing Authorisation for any Finished Product, approvals of such applications, marketing plans and similar information.

 

(2)                                 Monthly updated forecasts:

 

Each month Omthera shall provide ONC with a schedule of clearly defined manufacturing orders, including, but not limited to, delivery dates, delivery destinations, shipping instructions and any special handling requests. This schedule will also identify the following:

 

(a)                                 “FX Orders”: Fixed Manufacturing orders required for delivery in the following  [...***...]. These orders are firm.

 

(b)                                 “PL Orders”: Planned Manufacturing orders scheduled for delivery in months  [...***...], to follow. These are orders which have high probability of remaining firm at subsequent updates, eventually becoming FX Orders.

 

(c)                                  “FO Orders”: Forecasted Manufacturing orders scheduled for delivery in months  [...***...]. These are provisional orders which are likely to materialize as PL Orders but the quantity and timing may be different at each scheduled update.

 

Omthera shall be obligated to purchase at least  [...***...] of its FX Orders, at least [...***...] of its forecast PL Orders, and at least [...***...] of the FO Orders, unless there is a Supply Problem as described below in Section 2.09(3). ONC shall be capable of supplying up to [...***...] of such PL Orders, unless otherwise mutually agreed. ONC shall use commercially reasonable effort to supply the surplus quantities ordered. [...***...], the Parties will discuss in good faith the possibility of ONC fulfilling orders exceeding the [...***...] of such PL Orders in case the demand for Finished Product exceeds initial expectations.

 

(3)                                 Planning and capacity forecasts:

 

In addition to the [...***...] rolling forecasts referred to in Section 2.04(2), Omthera shall submit to ONC [...***...] indicative and non-binding forecast  (the “Capacity Forecast”) on [...***...] during the Term, whereby the [...***...] will represent the FX Order, PL Order and FO Order, and [...***...] will represent a yearly demand estimate. ONC shall within ninety (90) days of submission thereof, comment in writing on its capacity and capability to meet the Capacity Forecast. At any Party’s request, the Parties shall also meet in person quarterly to discuss relevant issues related to this Agreement, in particular for the year following such meeting, including in respect of Capacity Forecast and market conditions for the Finished Products.

 

2.05                        Orders:

 

All orders for Feedstock shall be in writing and submitted either by fax or electronic mail to an address designated for such by ONC from time to time.

 

***Confidential Treatment Requested

 

12

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Individual orders shall not be binding on ONC unless and until acknowledged by ONC within five (5) Business Days of receipt. Any contractual term set out in any purchase order, acknowledgement or invoice shall not be binding on any of the Parties unless such term is expressly agreed to by an instrument in writing signed by the Parties.

 

2.06                        Shipment:

 

Each lot of Feedstock shall be shipped in the type of packaging or containers specified in the Specifications, and each container will be clearly labelled with the weight, name, lot number, and expiration date. In addition, ONC shall ship by overnight courier to the delivery recipient one or more Feedstock test samples (“Test Samples”) for each lot of Feedstock, with targeted delivery expected before receipt of the corresponding Feedstock delivery. Omthera shall be provided with each delivery the commercial invoice bearing the applicable order number relating to such delivery and any other agreed delivery documentation, including a Delivery Note, a Certificate of Analysis, a Certificate of Compliance and a Certificate of Origin and a list of change controls and deviations for that particular batch or batches. At Omthera’s request, ONC shall provide Omthera with reasonable access to and copies of any applicable supporting data (such as batch records, internal and external lab results and the like) in ONC’s possession, available to ONC or that ONC is able to obtain using commercially reasonable efforts.

 

2.07                        Delivery:

 

Delivery shall take place within the period from [...***...] the delivery date contained in the FX Order and agreed-to by ONC. If Feedstock is incorrectly delivered according to the Firm Order, ONC shall be liable for reasonable and documented additional expense incurred in delivering it to the correct point specified in the Firm Order.

 

2.08                        Shelf Life:

 

At the time of delivery of Feedstock by ONC, the remaining Shelf Life of such Feedstock shall be not less than  [...***...] of the Shelf Life period if [...***...] and [...***...]of the Shelf Life period [...***...]. This Shelf Life requirement shall form part of the Specifications under this Agreement. The Parties shall collaborate on conducting stability studies demonstrating longer shelf life.

 

2.09                        Acceptance of the Feedstock:

 

(1)                                 Deemed acceptance:

 

If Omthera does not notify ONC in accordance with Section 2.09(2), then Omthera will be deemed to have accepted the Feedstock.

 

(2)                                 Notice:

 

Omthera or its Licensee, as applicable, shall inspect and test the Test Samples for each lot of Feedstock received and shall forthwith notify ONC in writing of any

 

***Confidential Treatment Requested

 

13

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

alleged deficiencies related to the warranties provided hereunder or failure to meet the Specifications. Omthera will have the Notice Period (defined below) to address any alleged deficiencies, and during the Notice Period, Omthera shall consult with ONC on testing and results. If Omthera notifies ONC in writing before the end of the Notice Period that Omthera believes any of the Feedstock did not conform to the Specifications or warranties at the time of delivery to Omthera, Omthera will contact ONC and attempt to resolve the matter and if after a period of thirty (30) days Omthera is not satisfied and has obtained independent verification by an independent testing laboratory, such laboratory approved by both Parties, that the Feedstock did not conform to the Specification at the time of delivery to Omthera:

 

(a)                                 ONC will, at its expense, replace any such defective Feedstock within  [...***...] like an FX Order hereunder; and

 

(b)                                 all quantities of defective Feedstock will, at ONC’s election and expense be either (i) returned to ONC at ONC’s expense; or (ii) destroyed by Omthera under ONC’s direction at ONC’s cost.

 

“Notice Period” means (i) [...***...] days for [...***...] beginning with [...***...], and (ii) [...***...] thereafter.

 

Upon detection of a Latent Defect by Omthera or ONC the other Party will be notified in writing within [...***...] and if the Latent Defect is attributable to ONC as described below, Sections 2.09(2)(a) and 2.09(2)(b) will be applicable. Upon any such notification, the Parties will meet and discuss, and a plan to test for and determine whether the Latent Defect is attributable to ONC will be put into action, with a goal of making that determination promptly and in any event with [...***...]. If Omthera and ONC are unable to agree on such plan or disagree on such determination, then Omthera and ONC shall mutually agree upon an independent third party to address the situation and render a determination, which determination shall be final and binding. The cost of the independent third party shall be borne by  [...***...].

 

(3)                                 Supply Problem:

 

A “Supply Problem” means that for  [...***...], or for [...***...], Sections 2.09(2)(a) and 2.09(2)(b) are applied to those shipments. In such event, then without limiting any other remedies of Omthera, Omthera shall not be required to make any further Feedstock Purchases, until the Parties resolve the source(s) of the Supply Problem. If ultimately it is determined that any such sources are not ONC’s responsibility, then the Parties shall agree on appropriate compensation for Omthera to pay ONC for any orders that were not placed as required by Section 2.04(2).

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

2.10                        Incomplete Delivery:

 

(1)                                 Omthera shall notify ONC in writing as soon as reasonably practicable if there is an incomplete delivery according to the terms of this Agreement and a confirmed FX Order. ONC shall thereafter use its commercially reasonable efforts to deliver the shortfall as soon as possible, but no later than [...***...] days of the intended delivery date under the FX Order, provided this shall be without prejudice to any other rights or obligations under this Agreement.

 

(2)                                 If the shortfall for delivery of any FX Order exceeds [...***...], then without limiting any other remedies of Omthera under this Agreement, the following terms shall apply:

 

(a)                                 If the shortfall is  [...***...]:

 

(i)                                     [...***...] shall apply for delivery of the shortfall; and

 

(ii)                                  If the complete delivery of the shortfall occurs after  [...***...], the Supply Price for the shortfall quantity [...***...] shall be reduced by [...***...], and [...***...].

 

(b)                                 If the shortfall is  [...***...]:

 

(i)                                     [...***...] shall apply for delivery of the shortfall;

 

(ii)                                  If the complete delivery of the shortfall occurs after  [...***...], the Supply Price for the shortfall quantity [...***...]shall be reduced by [...***...], and [...***...]; and

 

(c)                                  If the complete delivery of the shortfall occurs  [...***...] after the FX Order, ONC shall also pay to Omthera, [...***...], and [...***...], in each case of the Supply Price (as per the FX Order) for the shortfall quantity [...***...].

 

(3)                                 The above terms of Section 2.10(2) shall not apply to a shortfall caused by a Force Majeure Event, and the application of Section 2.10(2) shall not release the Parties from their obligations and liabilities under this Agreement.

 

2.11                        Safety Stock:

 

[...***...], the Parties will agree on a safety stock plan that the Parties will update during the Term as appropriate.

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

2.12                        Certificate of Analysis; Material Safety Data Sheet:

 

ONC shall retain the following information and documentation (per cGMP requirements) with respect to Feedstock delivered to Omthera, and provide such information and documentation to Omthera upon its request in a form reasonably acceptable to Omthera:

 

(a)                                 Certificates of Analysis, Compliance and Origin;

 

(b)                                 a Delivery Note;

 

(c)                                  batch documentation for the Feedstock; including a summary of the deviations properly closed and changes and all of the in process and final QC analysis with back up;

 

(d)                                 a copy of the Specifications;

 

(e)                                  the test methods used by ONC in respect of the Feedstock (including validation testing); and

 

(f)                                   any other documentation which Omthera may be required to provide to regulatory authorities from time to time in connection with ONC’s manufacture of the Feedstock or supply, distribution or other disposal of the Finished Product.

 

2.13                        Payment:

 

[...***...], Omthera shall pay to ONC [...***...] of the purchase price for the Feedstock set out in the relevant FX Order. The balance of the purchase price shall be due and payable on [...***...]. Overdue invoices shall accrue simple interest at a rate of [...***...]. In the event that invoices remain outstanding for [...***...], ONC may adjust the payment terms for future orders consistent with its credit practices. After [...***...] of prompt payment, the original [...***...] credit terms will be restored.

 

2.14                        Exclusivity:

 

Provided the following criteria under clauses (a), (b) and (c) are met by Omthera (and in such regard provided ONC meets its obligations under this Agreement), ONC and its subsidiaries will not manufacture, develop, market, sell or supply any other person or entity (other than Omthera and its Licensees), or license or enable (in either case in whole or in part) any others to do the same, with  [...***...]:

 

(a)                                 [...***...];

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(b)                                 [...***...]

 

(c)                                  [...***...].

 

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

 

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

 

2.15                        Regulatory compliance:

 

(1)                                 ONC acknowledges and agrees that the Feedstock is intended to be used as a feedstock for an active pharmaceutical ingredient and is required to be manufactured, processed and handled in accordance with the measures required by the

 

(2)                                 Relevant Regulatory Authorities (including all cGMP requirements outlined in the CofR, MHRA and ICHQ7A guidelines), provided such measures to the

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

extent not in cGMP are communicated to ONC. All Feedstock manufactured by ONC and supplied to Omthera shall be manufactured, processed and handled in accordance with such guidelines. In addition to such obligations, ONC will:

 

(a)                                 fully and promptly disclose to Omthera relevant matters pertaining to the Feedstock and any supporting documentation for the purposes of Omthera or its Licensees obtaining Marketing Authorisation in respect of any Finished Product;

 

(b)                                 at Omthera’s cost, promptly provide to Omthera a sufficient quantity of the Feedstock and all assistance and other documents reasonably necessary for Omthera to prepare any application, and the grant, maintenance, variation or renewal of any Marketing Authorisation in respect of any Finished Product;

 

(c)                                  use its best endeavours to assist Omthera in meeting the demands of any Relevant Regulatory Authority relating Omthera’s or its Licensee’s application and any grant, maintenance, variation or renewal of each Marketing Authorisation in respect of any Finished Product; and

 

(d)                                 ONC will share any observation(s) (such as Form 483 observations) made by Regulatory Agencies during their inspections with Omthera.

 

(3)                                 ONC  shall not reprocess or rework any material used in manufacturing Feedstock, or the Feedstock itself, without prior written authorization by Omthera, unless such reprocess or rework is permitted under the applicable Marketing Authorisation.

 

(4)                                 At Omthera’s request, with advance notice of not less than thirty (30) days, Omthera shall have right to have up to [...***...]  observe the manufacture of Feedstock at ONC’s site(s), provided that absent ONC’s consent, not to be unreasonably withheld, this right may be exercised by [...***...], and then [...***...], in which event [...***...]  Omthera may exercise this observation right up to [...***...]. ONC will cooperate in any such observation by Omthera, and Omthera will cooperate to ensure that ONC is able to protect the confidential information of its other customers.

 

(5)                                 ONC shall notify Omthera in writing if ONC desires to make any changes to the manufacturing and quality control processes, equipment, ingredients, sources of supply, location or other aspects for manufacturing Feedstock (other than Incoming Fish Oil, provided the Incoming Fish Oil Specifications are satisfied), from those included in the filing for Marketing Authorisation with the FDA for Epanova.

 

(a)                                 If Omthera concludes that such change will not require any filing with the FDA other than as part of the annual required

 

***Confidential Treatment Requested

 

18

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

filing with the FDA (or its equivalent with foreign Relevant Regulatory Authorities), and further that such change does not pose any material risk to the regulatory status of Epanova or any other Finished Product (a “Material Regulatory Risk”), then ONC may make such change.

 

(b)                                 Alternatively, if the proposed change requires any other regulatory filing, or in Omthera’s reasonable view could pose such a Material Regulatory Risk, then ONC will not make such change without Omthera’s prior written consent, not to be unreasonably withheld, provided that Omthera may withhold its consent or may require ONC to delay such change if in Omthera’s reasonable judgment making such change presents any Material Regulatory Risk.

 

(c)                                  In any event, no such changes shall be made after filing for the first Marketing Authorisation for Epanova until Marketing Authorisation is obtained unless required to meet regulatory requirements and then only with Omthera’s prior written consent.

 

Omthera will be responsible for obtaining approval of ONC suggested changes (subject to the foregoing) to ensure ONC operations will not be adversely affected. ONC recognizes that there are no guarantees that Relevant Regulatory Authorities will approve the requested changes and Omthera commits to process changes in good faith. Omthera shall reply with its approval or objection to any ONC proposal for any change described in this Section within ten (10) Business Days after receiving a complete description of such change and any other information regarding such change as Omthera may reasonably request.

 

(6)                                 Audit:

 

ONC shall permit Omthera, its Licensees and regulatory consultants retained by either of them, or any Relevant Regulatory Authority to carry out periodic audits (as needed during the licensing process and once a year thereafter) of ONC’s records and facilities for the sole purpose of verifying compliance with ONC’s obligations under Section 2.15. As a condition of access to ONC’s premises, ONC may require that any individual acting on behalf of Omthera, its Licensees or consultants enter into a confidentiality agreement to protect the confidentiality of ONC’s confidential information and trade secrets. All such audits shall be at the expense of the Party carrying out the audit or inspection, except that neither Omthera nor its Licensees shall pay for audits and inspections carried out by or on behalf of Relevant Regulatory Authorities, and Omthera shall not be responsible for ONC’s costs arising from assistance and compliance with an audit or inspection.

 

2.16                        Representations and Warranties:

 

ONC represents and warrants that:

 

(a)                                 The Feedstock shall conform to the Specifications;

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(b)                                 The Incoming Fish Oil used in the Feedstock shall conform to the Incoming Fish Oil Specifications;

 

(c)                                  The Feedstock shall be produced in accordance with the Production Standards, including as such Production Standards are amended by the agreement of the Parties from time to time;

 

(d)                                 The Certificate of Analysis, Certificate of Origin and Certificate of Origin accompanying any order of Feedstock shall be accurate in all respects;

 

(e)                                  The Feedstock shall be produced in compliance with the requirements of the Relevant Regulatory Authorities and all Applicable Laws (including cGMP) and have not been, are not and will not be adulterated or misbranded within the meaning of the Federal Food Drug and Cosmetic Act of 1938, as amended (the “Act”); ICHQ7A, MHRA, CofR and other applicable regulations;

 

(f)                                   ONC has the right to convey title to the Feedstock, free of all third-party claims and encumbrances;

 

(g)                                  ONC has good title to all Feedstock provided to Omthera pursuant to this Agreement and passes such title to Omthera free and clear of any security interests, liens or other encumbrances;

 

(h)                                 ONC is not debarred under subsections 306(a) or (b) of the Act and that it has not and will not use in any capacity the services of any person or entity debarred under such law with respect to its performance of this Agreement. ONC will immediately notify Omthera in writing in the event that it or any such person or entity is debarred during the Term;

 

(i)                                     The execution, delivery and performance of this Agreement by ONC does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which is may be bound, and does not violate any law or regulation of any court, governmental body or administrative or other agency having authority over it; ONC is not currently a party to, and during the Term will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement (including any agreement, instrument or understanding, oral or written, that would prevent Omthera from using any Licensee as contemplated hereunder);

 

(j)                                    To the best of ONC’s knowledge, the Feedstock, and the processes used by ONC to manufacture the Feedstock, do not infringe any third party issued patents in Canada, the United States and Europe that will ultimately be found to be valid;

 

***Confidential Treatment Requested

 

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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(k)                                 ONC is validly existing and in good standing under the laws of the jurisdiction of its incorporation and has the corporate power and authority to enter into this Agreement. This Agreement has been duly executed and delivered by ONC and constitutes the valid and binding obligation of ONC, enforceable against it in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery, and performance of this Agreement have been duly authorized by all necessary action on the part of ONC, its officers and directors.

 

(l)                                     ONC maintains all valid governmental and regulatory permits and licenses as required to produce and deliver the Feedstock in accordance with this Agreement.

 

EXCEPT AS SET FORTH IN THIS SECTION 2.16, ONC MAKES NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE PRODUCTS MANUFACTURED BY IT HEREUNDER AND SPECIFICALLY DISCLAIMS ALL SUCH OTHER REPRESENTATIONS AND WARRANTIES, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

2.17        Indemnification:

 

(a)                                 Omthera agrees to defend, indemnify and hold harmless ONC, its Affiliates, and their respective officers, directors, employees, agents and representatives from and against any and all Losses to the extent arising out of (a) any breach by Omthera of its representations, warranties or obligations under this Agreement, (b) any sale, promotion, distribution or use of or exposure to the Finished Products, including product liability or strict liability, (c) any claim that the manufacture of Feedstock by ONC in compliance with this Agreement (including in compliance with the Specifications) infringes any patent rights of a third party, (d) any negligence or wilful misconduct by Omthera, or (e) any failure by Omthera to comply with Applicable Laws in the performance of its obligations under this Agreement, except to the extent that any of the foregoing arises out of or results from ONC’s indemnification obligations under clause (b) below. ONC shall promptly notify Omthera in writing of any such claim or action, shall reasonably co-operate with Omthera in the defence of such claim or action, and shall permit Omthera to control the defence and settlement of such claim or action, all at Omthera’s cost and expense.

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

(b)                                 ONC shall defend, indemnify and hold harmless Omthera, its Affiliates, and their respective officers, directors, employees, Licensees, agents and representatives from and against any and all Losses to the extent arising out of (a) any claim of personal injury, bodily injury or property damage arising from breach of any of ONC’s representations, warranties or obligations under this Agreement, (b) any Feedstock that does not meet the Specifications, (c) any negligence or wilful misconduct by ONC, (d) any breach by ONC of its representations, warranties or obligations under this Agreement, (e) any failure by ONC to comply with Applicable Laws in the performance of its obligations under this Agreement, or (f) any claim regarding a work-related injury to any employee or consultant of ONC, except to the extent that any of the foregoing arises out of or results from Omthera’s indemnification obligations under clause (a) above. Omthera shall promptly notify ONC in writing of any such claim or action, shall reasonably co-operate with ONC in the defence of such claim or action, and shall permit ONC to control the defence and settlement of such claim or action, for so long as the ONC’s conduct is reasonable, proper and timely and does not prejudice the rights and interests of the Omthera, all at ONC’s cost and expense.

 

(c)                                  Should a third party allege or claim that the manufacture, import, promotion, sale, distribution or use of the Finished Product or the manufacture, import, promotion, sale, distribution or use of a medicinal product containing the Finished Product infringes a third party’s patent or other intellectual property rights, ONC shall reasonably support Omthera in its defence against such claim, including by disclosing the route of synthesis of the Finished Product if beneficial for the purposes of such defence. ONC shall not be bound to make any disclosures that would place on the public record any ONC trade secrets or breach any obligations that ONC may have to any third party to keep such information confidential.

 

(d)                                 Should a third party allege or claim in writing that the manufacture, import, promotion, sale, distribution or use of the Feedstock infringes a third party’s patent rights or should a Party become aware of any third party’s patent rights that may reasonably be apprehended to affect either Party’s freedom to manufacture, import, promote, sell, distribute or use the Feedstock, at either Party’s request, the Parties shall collaborate to develop a non-infringing alternative, and if such alternative is not commercially feasible, then either Party may terminate this Agreement, at its option, on 

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

ninety (90) days advance written notice. ONC’s obligations to supply and Omthera’s obligations to purchase Feedstock shall be suspended while the Parties are developing or implementing any changes necessary related to a non-infringing alternative. Omthera may, at its option, require that ONC continue to supply Feedstock if Omthera agrees that it will fully indemnify ONC for any damages or losses that it may suffer due to alleged infringement.

 

2.18        Recalls and traceability:

 

(1)           General:

 

If Omthera determines that the Feedstock or any Finished Product must be subject to a field correction, withdrawn or recalled from the market (collectively, a “Regulatory Recall”), Omthera shall notify all regulatory authorities of any such Regulatory Recall, and shall take all steps necessary to effectuate such Regulatory Recall. ONC shall assist Omthera in carrying out any Regulatory Recall by supplying Omthera with relevant manufacturing records including process records, inspection records, material traceability records, and records of Feedstock shipment. ONC shall reimburse Omthera for the costs of such Regulatory Recalls to the extent such Regulatory Recalls were made necessary because of a failure of the Feedstock to meet the Specifications or the requirements of this Agreement at the time that such Feedstock is delivered to Omthera, but ONC shall incur no liability hereunder if ONC’s Feedstock conformed to this Agreement and to the Specifications. If Omthera and ONC are unable to agree on the extent that such Regulatory Recalls were made necessary because of the quality or condition of the Feedstock at the time that such Feedstock was delivered to Omthera, then Omthera and ONC shall mutually agree upon an independent third party to inspect the subject Feedstock and render a determination, which determination shall be final and binding. The cost of the independent third party shall be borne by the Party found by such independent third party to be at fault.

 

(2)           Obligation to notify:

 

ONC shall promptly and without delay notify Omthera in writing of any information or circumstances that come to its attention related to any Feedstock that has been sold to Omthera or its Licensees that suggest that any such Feedstock deviates from the Specifications such that its use in a Finished Product may be hazardous or may subject the Finished Product to a Regulatory Recall. If ONC recommends to Omthera, in writing, that any Finished Product containing any such Feedstock be recalled and Omthera makes such recall, then Section 2.18(1) shall apply, and if Omthera fails to recall such Finished Product, ONC shall have no liability for such Feedstock.

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Article Three. Term and Termination

 

3.01        Term:

 

This Agreement shall be in effect and binding upon the Parties from the Effective Date until the tenth anniversary of the Effective Date (the “Term”). Either Party may elect to extend the Term for a single five (5)-year extension (for a total Term of fifteen (15) years in such event) by providing written notice to the other Party at least twelve (12) months before the tenth anniversary of the Effective Date.

 

3.02        Termination:

 

(1)           Termination for breach, insolvency etc:

 

Either Party may terminate this Agreement, at its option, by written notice to the other Party if:

 

(a)                                 the other Party breaches this agreement; and (i) the breach is material and not capable of being cured; or (ii) the breach is capable of being cured and the defaulting Party fails to cure the breach to the first Party’s reasonable satisfaction within sixty (60) days after receipt of a written notice requesting the defaulting Party to do so;

 

(b)                                 the other Party is or becomes insolvent or is subject to bankruptcy proceedings that are not dismissed within sixty (60) days of commencement; or

 

(c)                                  the other Party is subject to a Force Majeure Event for a continuous period of one hundred twenty (120) days.

 

(2)           Termination by Omthera due to market conditions:

 

If Omthera determines in good faith and with reasonable evidence thereof that [...***...], then ONC and Omthera shall attempt to negotiate [...***...]. In the event that no agreement is reached between ONC and Omthera within [...***...] the commencement of negotiations, then either Party may terminate this Agreement upon [...***...] notice. ONC may request that Omthera provide third party expert advice regarding [...***...].

 

(3)           Termination by Omthera:

 

Omthera may terminate this Agreement, at its option, with immediate effect if:

 

(a)                                 ONC is unable to supply the Feedstock in accordance with FX Orders for a continuous period [...***...];

 

(b)                                 the application for Marketing Authorisation with the FDA for Epanova is rejected in such a manner that it would be

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

unreasonable to further attempt to seek Marketing Authorization with the FDA for Epanova;

 

(c)                                  it is not possibly to commercialize Epanova given market conditions;

 

(d)                                 ONC violates the non competition provisions of this Agreement in Section 2.14; or

 

(e)                                  Omthera and its licensees cease to market Finished Product as a result of an injunction or other order by courts of competent jurisdiction prohibiting the manufacture or sale of Finished Products in the Territory.

 

(4)           Termination by ONC:

 

ONC may terminate this Agreement, at its option, with immediate effect if:

 

(a)                                 any dispute or litigation is initiated which may reasonably be apprehended result in the prevention of the manufacture, storage, promotion, sale or distribution of Feedstock that is specific the Feedstock (and not to ONC more generally), unless Omthera is required by this Agreement to indemnify ONC or Omthera elects to indemnify ONC for same on terms substantially equivalent to those provided in Section 2.17 and  [...***...].

 

3.03        Effect of termination or expiration:

 

(a)                                 In the event of any termination under this Article Three, the day that is the effective date of termination shall be the last day of the Term.

 

(b)                                 Regardless of the reason for such termination, ONC may require, in its sole and absolute discretion, that Omthera shall purchase any and all inventory of Feedstock held by ONC at the time of any termination, subject to the Agreement requirements regarding Feedstock.

 

(c)                                  If this Agreement is terminated by Omthera under Sections 2.17(d), 3.02(1), 3.02(3)(a) or 3.02(3)(d), or if this Agreement expires on the tenth anniversary of the Effective Date because the Term is not extended by ONC as provided in Section 3.01, then Section 2.14 shall survive for [...***...] (without reference to the three criteria (a) through (c) therein).

 

(d)                                 Sections 2.14, 2.15, 2.16, 2.17, 2.18 and 3.03and Articles 1, 4 and 5 will survive the expiration or termination of this Agreement. All accrued rights and obligations of the Parties shall survive the expiration or termination of this Agreement (for clarity, Sections 2.01 through 2.13, and the other applicable terms of this Agreement, shall survive for any 

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Feedstock subject to an FX Order placed or shipped before any such expiration or termination).

 

Article Four. Confidentiality; Licensees; Intellectual Property

 

4.01        Disclosure: Standard of Care:

 

The Parties acknowledge that, in the course of performance of their obligations under this Agreement, each Party (a “Disclosing Party”) may disclose Confidential Information to the other (a “Receiving Party”). Each Receiving Party shall protect the other Party’s Confidential Information from unauthorized dissemination, disclosure and use with the same degree of care that each such Party uses to protect and safeguard its own like information, but not less than the degree of care that would be exercised by a prudent person given the sensitivity and strategic value of such Confidential Information. Confidential Information shall be disclosed only to the employees and consultants of the Receiving Party and its Affiliates who have a “need to know” and who have executed an internal nondisclosure agreement at least as restrictive as the terms of this Agreement. A Receiving Party shall not disclose any Confidential Information to any third party without first obtaining the Disclosing Party’s written consent to such disclosure, save that Omthera may disclose Confidential Information (i) to its Licensees, (ii) to prospective and actual collaborators, investors, lenders, acquirers, subcontractors and (sub)licensees, and (iii) to the licensor of Epanova to Omthera. A Receiving Party may further disclose Confidential Information to such Party’s professional advisors in connection with the negotiation and performance of this Agreement. In any case where a Receiving Party discloses a Disclosing Party’s Confidential Information to a third party as permitted under this Agreement, the Receiving Party shall ensure that the third party is subject to confidentiality obligations with the Receiving Party and the Receiving Party agrees to use commercially reasonable efforts to enforce such provisions to protect the Disclosing Party’s Confidential Information. The Specifications shall be treated as the Confidential Information of Omthera.

 

4.02        Compelled Disclosure:

 

In the event that a Receiving Party is compelled to disclose a Disclosing Party’s Confidential Information, in the course of litigation or otherwise, or a compelled disclosure is reasonably anticipated, the Receiving Party shall give immediate notice to the Disclosing Party of such fact and shall provide all reasonable cooperation to the Disclosing Party in obtaining a protective order to prevent the disclosure of Confidential Information.

 

4.03        Regulatory Disclosures:

 

Omthera shall be permitted to disclose ONC’s Confidential Information to a Relevant Regulatory Authority as required in order to obtain or maintain Omthera’s and its Licensee(s)’ Marketing Authorisations, but shall always be required to disclose the minimal amount of such Confidential Information and 

 

***Confidential Treatment Requested

 

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Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

shall make all reasonable efforts to prevent the disclosure of such Confidential Information beyond the Relevant Regulatory Authority.

 

4.04        Licensees:

 

(1)           The Parties acknowledge and agree that it is the intent of Omthera or its Affiliates to seek out and enter into agreements with Licensees to develop, manufacture, sell, distribute and commercialize Finished Product on Omthera’s behalf.

 

(2)           Omthera and its Affiliates will ensure that all Licensees are party to a confidentiality agreement for the protection of ONC’s Confidential Information on terms that are substantially similar to that which exists between Omthera and ONC in this Agreement.

 

4.05        Intellectual Property:

 

(1)           All Intellectual Property Rights, data, information, reports and any and all related documentation, which were developed, generated or derived, directly or indirectly by or on behalf Omthera prior to the Effective Date, including Omthera Manufacturing Know-How, or any improvements, modifications or enhancements thereto that are developed, generated or derived, directly or indirectly solely by Omthera during the Term, will remain the sole property of Omthera.

 

(2)           All Intellectual Property Rights, data, information, reports, and any and all related documentation, which were developed, generated or derived, directly or indirectly by ONC prior to the Effective Date, including ONC Manufacturing Know-How, or any improvements, modifications or enhancements thereto that are developed, generated or derived, directly or indirectly solely by ONC during the Term (collectively “ONC Intellectual Property”) will remain the sole property of ONC.

 

(3)           ONC confirms that is has not sought patent rights claiming Feedstock or its use, nor is ONC aware of anyone else doing so.

 

(4)           If ONC seeks patent protection for any (i) use for cardiovascular or neurological diseases, disorders and conditions (including dyslipidemia) or pancreatitis or (ii) composition, in each case for or that includes Feedstock, Omefas or Epanova, and such patent might reasonably be interpreted to hinder Omthera’s ability to make, have made, use, offer for sale, import, market or sell Feedstock, Omefas or Epanova, itself or through its Affiliates or Licensee(s), then without derogating from the licenses already granted herein, the licenses granted herein shall include licenses to such patent rights to make, have made, use, offer for sale, import, market and sell Feedstock, Omefas and Epanova.

 

(5)           If ONC seeks patent protection for any manufacturing process for or that includes Feedstock, and such patent might reasonably be interpreted to hinder Omthera’s ability to make, have made, use, offer for sale, import, market or sell Omefas or Epanova using the same or substantially the same processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera, itself or through its Affiliates or Licensee(s), then without 

 

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27

 

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with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

derogating from the licenses herein, the licenses granted herein shall include licenses to such patent rights to make, have made, use, offer for sale, import, market and sell Omefas and Epanova using the same or substantially the same processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera.

 

(6)           If and to the extent that any ONC Intellectual Property Rights or other Intellectual Property Rights owned or controlled by ONC is (i) disclosed (before or after the Effective Date) to Omthera or its Licensee(s) or (ii) is necessary to convert Feedstock or other intermediates into Omefas, ONC hereby grants to Omthera and its Affiliates a worldwide, perpetual and irrevocable, paid up, non-exclusive license, with the right to sublicense through multiple tiers, to such ONC Intellectual Property and Intellectual Property Rights, for use in connection with the making, using and commercialization of Omefas from Feedstock supplied by ONC hereunder, or other intermediates. Without limiting the generality of the foregoing, ONC agrees that it will not unreasonably claim infringement of any ONC Intellectual Property or other Intellectual Property Rights in connection with Omthera’s or its Affiliates’ or Licensees’ efforts to develop the manufacturing process for the Feedstock or other intermediates or Omefas using techniques and technologies that are commonly used in the lipid fractionation industry or available in the public domain.

 

(7)           All data, images, information, documents, records in whatever form obtained, developed, recorded or compiled (i) in connection with this Agreement that relates to the Feedstock, including its development, manufacture or use, or (ii) based upon or utilizing Omthera Confidential Information (collectively, “Omthera Data”) will be gathered, stored, secured, managed and maintained by ONC in accordance with Applicable Laws. Promptly upon the expiration or termination of this Agreement, and otherwise upon Omthera’s request, ONC will promptly provide originals or a copy (as applicable) of all Omthera Data to Omthera in a form acceptable to Omthera, and Omthera and its Licensees will have the right to use same.

 

(8)           During the Term, ONC will make the Pfaudler Wiped Film Evaporator presently at BioVectra Inc. available for the conversion of Feedstock and other intermediates into Finished Product for the benefit of Omthera.

 

4.06        Knowledge Transfer:

 

(1)           ONC will collaborate with Omthera and its Licensees during the Term, including, among other things, with respect to the disclosure and transfer of ONC Intellectual Property during the Term as needed to convert Feedstock to Omefas using the same or substantially the same processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera. As an initial matter, and without limiting the generality of the foregoing, ONC will meet with Croda International plc and Omthera at a neutral site, and further upon Omthera’s request and at Omthera’s expense, ONC will send one or more technical consultants to Croda International plc’s site to assist with manufacture of Omefas from Feedstock there using the same or substantially the same 

 

***Confidential Treatment Requested

 

28

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera. ONC agrees that Omthera may seek similar assistance for up to two other Licensees beyond Croda International plc. ONC agrees that ONC will disclose to such Licensees all Intellectual Property Rights owned or controlled by ONC that Omthera and its Licensees will need to convert Feedstock to Omefas using the same or substantially the same processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera.

 

(2)           ONC hereby grants to Omthera and its Affiliates a worldwide, perpetual, irrevocable, paid up, non-exclusive license, with the right to sublicense through multiple tiers, to such Intellectual Property Rights owned or controlled by ONC that are reasonably necessary to develop, make, use, sell, distribute or commercialize Feedstock (or any intermediate thereof), including for the conversion of Feedstock to Omefas using the same or substantially the same processes used by ONC and BioVectra to manufacture the Feedstock and Omefas previously delivered to Omthera; provided, however, that the foregoing license shall not be exercisable until the occurrence of the earliest to occur of the following events:

 

(a)                                 ONC fails to deliver Feedstock in accordance with the forecasts issued hereunder,

 

(b)                                 ONC does not comply with Applicable Laws in connection with the performance of its obligations under this Agreement,

 

(c)                                  ONC causes any delay in Omthera’s or its Licensees’ ability to obtain a Marketing Authorisation anywhere in the Territory,

 

(d)                                 any early termination of this Agreement by ONC other than due to the material, uncured breach of this Agreement by Omthera or

 

(e)                                  ONC does not have production capacity to supply 50% of Omthera, its Affiliates and its Licensees’ requirements for Feedstock.

 

Article Five. General

 

5.01        Condition precedent:

 

This Agreement shall be of no force and effect unless and [...***...]. In addition, Omthera shall use commercially reasonable efforts to [...***...]

 

***Confidential Treatment Requested

 

29

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

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

 

5.02        Insurance:

 

Each Party shall procure at its own expense from a reputable insurer, and maintain in full force and effect for the Term and for [...***...] thereafter, product liability, accidental contamination and malicious tamper insurance with a single limit liability of not less than [...***...], for bodily injury, death or property damage relating to the Feedstock. Prior to the first shipment of Feedstock to Omthera, each Party will provide the other with a copy of such policy or a certificate of insurance evidencing the required coverage and will further provide each other Party with evidence from time to time that the policy remains in force.

 

5.03        Limitation of Liability:

 

Except with respect to a Party’s indemnification obligations hereunder, the total aggregate amount that a Party shall be liable for and required to pay in respect of losses, damages, claims, costs or expenses (collectively “Losses”) that are asserted against or suffered by the other Party arising out of, in connection with or based upon the breach or failure to perform the provisions of this Agreement shall not exceed [...***...]. The foregoing shall not be applied to limit Omthera’s right to seek specific performance from ONC hereunder and thereby to require ONC to perform its obligations hereunder, but such shall not limit or derogate from ONC’s ability to terminate this Agreement as otherwise provided for in this Agreement.

 

Nothing in this Agreement shall exclude or limit the liability of either Party for death or personal injury caused by its negligence.

 

In no event shall either Party be liable to the other for indirect, special, incidental, punitive or consequential damages incurred by the other Party and arising out of or in connection with this Agreement for any cause of action of any kind even if the other Party has advised the first Party of the possibility of such damages.

 

5.04        Publicity:

 

If a Party intends to make any public announcement or release related to this Agreement or its subject matter, that Party shall give five (5) Business Days’ notice to the other Party and shall afford such Party the opportunity to assist or to be included in such announcement or release.

 

5.05        Entire Agreement:

 

This Agreement constitutes the entire understanding of the Parties with respect to the subject matter hereof and supersedes all prior agreements, understandings and negotiations, both written and oral, between the Parties with respect to the subject matter hereof and thereof. No representation, inducement,

 

***Confidential Treatment Requested

 

30

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

promise, understanding, condition or warranty not set forth herein, or incorporated by reference herein, has been made or relied upon by any Party hereto.

 

5.06        Governing Law:

 

This Agreement shall be construed in accordance with and governed by the laws in effect in the State of New York, without regard to the conflict of laws rules thereof.

 

5.07        Force Majeure:

 

Neither Party shall be liable for any damages, delays or failure in performance under this Agreement caused by acts or conditions beyond its reasonable control or without its fault or negligence (a “Force Majeure Event”), including but not limited to “acts of God”, delays caused by governmental authorities, strikes, lockouts and other labour unrest, delays in obtaining governmental approvals and similar conditions. For the avoidance of doubt, any circumstances beyond the control of ONC related to the fishery from which raw materials for the Feedstock are drawn that substantially affects the ability of ONC to procure Incoming Fish Oil for its business shall be a Force Majeure Event. A Party shall, in order to avail itself of any of the provisions of this Section, forthwith send a written notice of the Force Majeure Event to the other Party, including a description of the Force Majeure Event, its expected duration and the Party shall use commercially reasonable efforts to mitigate the effect of the Force Majeure Event and provide a description of the actions being taken by the Party to mitigate the effect of the Force Majeure Event. Any inability of a Party to pay any amounts owing shall not be a Force Majeure Event.

 

5.08        Severability:

 

The Parties acknowledge and agree that each and every term of this Agreement is of the essence. If any one or more of the provisions contained in this Agreement should be declared invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained in this Agreement shall not in any way be affected or impaired thereby so long as the commercial, economic and legal substance of the transaction contemplated hereby are not affected in any manner materially adverse to any Party. Upon such a declaration, the Parties shall modify this Agreement so as to carry out the original intent of the Parties as closely as possible in an acceptable manner so that the transactions contemplated hereby are consummated as originally contemplated to the fullest extent possible.

 

5.09        Further Assurances:

 

Each Party shall at any time and from time to time, upon each request by the other Party, execute and deliver such further documents and do such further acts and things as the other Party may reasonably request to evidence, carry out and give full effect to the terms, conditions, intent and meaning of this Agreement.

 

***Confidential Treatment Requested

 

31

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Notwithstanding any other provision of this Agreement, the provisions of this Section shall survive any termination of this Agreement.

 

5.10        No Amendments:

 

This Agreement may not be amended or modified, nor may any right or remedy of any Party be waived, except in writing, signed by such Party. The waiver by any Party of the breach of any term or provision hereof by any other Party will not be construed as a waiver of any other subsequent breach.

 

5.11        No Assignment:

 

No Party may assign its rights or obligations hereunder without the prior written consent of the other Parties, except that a Party may assign this Agreement

 

(a)                                 To an Affiliate; or

 

(b)                                 In connection with any sale of all or substantially all of its business related to the subject matter of this Agreement.

 

Provided, however, that the assignee agrees to be bound by the terms of this Agreement. This Agreement is strictly between ONC and Omthera, and nothing in this Agreement, express or implied, is intended to or shall confer upon any other person or entity any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement. No other person or entity may enforce it for their benefit, nor shall they have any claim or remedy for its breach.

 

5.12        No Waiver:

 

No failure or delay by any Party in exercising any of its rights or remedies hereunder will operate as a waiver thereof, nor will any single or partial exercise of any such right or remedy preclude any other or further exercise thereof or the exercise of any other right or remedy. Except as otherwise provided herein, the rights and remedies of the Parties provided in this Agreement are cumulative and not exclusive of any rights or remedies provided under this Agreement, by law, in equity or otherwise.

 

5.13        No Agency:

 

The Parties are not partners or joint venturers; neither Party is the agent, representative, or employee of the other Party; and nothing in this Agreement will be construed to create any relationship between them other than an independent contractor relationship. Neither Party will have any responsibility or liability for the actions of the other Party except as specifically provided herein. Neither Party will have any right or authority to bind or obligate the other Party in any manner or make any representation or warranty on behalf of the other Party.

 

5.14        Notices:

 

All notices, consents and other communications required or which may be given under this Agreement will be in writing and will be deemed to have been duly given (a) when given by hand or by courier; or (b) when received by the addressee if sent by facsimile transmission during business hours of the 

 

***Confidential Treatment Requested

 

32

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

addressee. If sent outside business hours of the addressee, such notice, consent or other communication will be deemed to have been duly given at the beginning of the next Business Day. Notices, consents and other communications shall be addressed to a Party at its address set forth below, or at such other address as a Party may hereafter designate by notice given in accordance with the terms hereof:

 

If for ONC:

 

Ocean Nutrition Canada Limited

101 Research Drive

Dartmouth NS B2Y 4T6

Fax: 1 902 480 3199

Attention: President/CEO

 

with a copy to:

 

McInnes Cooper

Purdy’s Wharf, Tower II

1300-1969 Upper Water Street

Halifax, NS B3J 3P6

Fax: (902) 425-6350

Attention: David T.S. Fraser

 

If for Omthera:

 

Omthera Pharmaceuticals Inc.

707 State Road

Princeton, NJ 08540

Fax: (908) 741-4398

Attention: President/CEO

 

5.15        Counterparts:

 

This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each Party hereto shall have received an original or faxed counterpart hereof signed by each other Party hereto.

 

***Confidential Treatment Requested

 

33

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

* * *

 

IN WITNESS WHEREOF the Parties have executed this Agreement as of the date first above written.

 

	
SIGNED,   SEALED AND DELIVERED
   in the presence of:
    	
 
    	
Ocean Nutrition Canada Limited
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
Per:
    	
/s/ M.R. Jamieson
    
	
Witness:
    	
 
    	
Name:
    	
M.R. Jamieson
    
	
 
    	
 
    	
Title:
    	
President * CEO
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Omthera   Pharmaceuticals Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Per:
    	
/s/ Gerald Wisler
    
	
Witness:
    	
 
    	
Name:
    	
Gerald Wisler
    
	
 
    	
 
    	
Title:
    	
President & CEO
    

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule “A” — Specifications for the Feedstock

 

See attached.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Technical Data Sheet

 

[...***...]

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule “B” — Supply Price Variability related to Cost of Crude Fish Oil

 

[...***...]

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule “C” - Current Launch Plans

 

[...***...]

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule “D” - Production Standards

 

To be completed by the Parties at the same time as the Quality Technical Agreement.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule “E” - Incoming Fish Oil Specifications

 

See attached.

 

***Confidential Treatment Requested

 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

Schedule E

 

[...***...]

 

***Confidential Treatment Requested

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