ARTICLE 1 STRUCTURE OF AGREEMENT AND INTERPRETATION

1

1.1

Master Agreement.

1

1.2

Product Agreements.

2

1.3

Definitions.

2

1.4

Currency.

8

1.5

Sections and Headings.

8

1.6

Singular Terms.

8

1.7

Appendix 1, Schedules and Exhibits.

8

ARTICLE 2 PATHEON'S MANUFACTURING SERVICES

9

2.1

Manufacturing Services.

9

2.2

Active Material Yield.

11

ARTICLE 3 CLIENT'S OBLIGATIONS

13

3.1

Payment.

13

3.2

Active Materials and Qualification of Additional Sources of Supply.

13

ARTICLE 4 [* * *] COMPONENT COSTS

14

4.1

First Year Pricing.

14

4.2

Price Adjustments – Subsequent Years’ Pricing.

14

4.3

[* * *].

16

4.4

Price Adjustments – Current Year Pricing.

16

4.5

Adjustments Due to Technical Changes or Regulatory Authority Requirements.

17

4.6

Multi-Country Packaging Requirements.

17

ARTICLE 5 ORDERS, SHIPMENT, INVOICING, PAYMENT

17

5.1

Orders and Forecasts.

17

5.2

Reliance by Patheon.

19

5.3

Minimum Orders.

20

5.4

Delivery and Shipping.

20

5.5

Invoices and Payment.

20

ARTICLE 6 PRODUCT CLAIMS AND RECALLS

20

6.1

Product Claims.

20

6.2

Product Recalls and Returns.

21

6.3

Patheon’s Responsibility for Defective and Recalled Products.

22

6.4

Disposition of Defective or Recalled Products.

22

6.5

Healthcare Provider or Patient Questions and Complaints.

23

6.6

[* * *].

23

ARTICLE 7 CO-OPERATION

23

7.1

Quarterly Review.

23

7.2

Governmental Agencies.

23

7.3

Records and Accounting by Patheon.

23

7.4

Inspection.

24

7.5

Access.

24

7.6

Notification of Regulatory Inspections.

24

7.7

Reports.

24

7.8

Regulatory Filings.

24

7.9

Technology Transfer.

26

ARTICLE 8 TERM AND TERMINATION

26

8.1

Initial Term.

26

8.2

Termination for Cause.

27

8.3

Obligations on Termination.

27

ARTICLE 9 REPRESENTATIONS, WARRANTIES AND COVENANTS

29

9.1

Authority.

29

9.2

Client Warranties.

29

9.3

Patheon Warranties.

30

9.4

Permits.

31

9.5

No Warranty.

31

ARTICLE 10 REMEDIES AND INDEMNITIES

31

10.1

Consequential and Other Damages.

31

10.2

Limitation of Liability.

31

10.3

Patheon Indemnity.

32

10.4

Client Indemnity.

32

10.5

Reasonable Allocation of Risk.

33

ARTICLE 11 CONFIDENTIALITY

33

11.1

Confidential Information.

33

11.2

Use of Confidential Information.

33

11.3

Exclusions.

34

11.4

Photographs and Recordings.

34

11.5

Permitted Disclosure.

34

11.6

Marking.

35

11.7

Return of Confidential Information.

35

11.8

Remedies.

35

ARTICLE 12 DISPUTE RESOLUTION

35

12.1

Commercial Disputes.

35

12.2

Technical Dispute Resolution.

36

ARTICLE 13 MISCELLANEOUS

36

13.1

Inventions.

36

13.2

Intellectual Property.

37

13.3

Compliance with Tufts License.

37

13.4

Insurance.

39

13.5

Independent Contractors.

39

13.6

No Waiver.

40

13.7

Assignment and Subcontracting.

40

13.8

Force Majeure.

41

13.9

Additional Product.

41

13.10

Notices.

41

13.11

Severability.

42

13.12

Entire Agreement.

42

13.13

Other Terms.

42

13.14

No Third Party Benefit or Right.

42

13.15

Execution in Counterparts.

43

13.16

Use of Client Name.

43

13.17

Taxes.

43

13.18

Governing Law.

44

13.19

Further Assurances..

45

13.20

Supply and Quality Committee

45

(a)

a business entity which owns, directly or indirectly, a controlling interest in a Party to this Agreement, by stock ownership or otherwise; or

(b)

a business entity which is controlled by a Party to this Agreement, either directly or indirectly, by stock ownership or otherwise; or

(c)

a business entity, the controlling interest of which is directly or indirectly common to the majority ownership of a Party to this Agreement;

(a)

Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations;

(b)

EC Directive 2003/94/EC; and

(c)

Division 2 of Part C of the Food and Drug Regulations (Canada);

(a)

specifications for Active Materials and Components;

(b)

manufacturing specifications, directions, and processes;

(c)

storage requirements;

(d)

all environmental, health and safety information for each Product including material safety data sheets; and

(e)

the finished Product specifications, packaging specifications and shipping requirements for each Product;

Appendix 1

-

Form of Product Agreement (Including Schedules A to D)

Exhibit A

-

Technical Dispute Resolution

Exhibit B

-

Quarterly Active Materials Inventory Report

Exhibit C

-

[* * *]

(a)

Conversion of Active Materials and Components.  Patheon will convert Active Materials and Components into Product.

(b)

Quality Control and Quality Assurance.  Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement.  Batch review and release to Client will be the responsibility of Patheon’s quality assurance group.  Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures.  Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs.  Client will have sole responsibility for the release of Products to the market.  The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon.  Specific Product related information contained in those batch documents is Client property.

(c)

Components.  Patheon will purchase all Components (with the exception of Client-Supplied Components) and will test all Components (including Client-Supplied Components) at Patheon's expense and as required by the Specifications.  Agreed Component Specifications shall be established in writing.  Patheon shall only perform I.D. testing unless otherwise agreed in writing.

(d)

Stability Testing.  Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement.  Patheon will not make any changes to these testing protocols without prior written approval from Client.  If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be

undertaken to investigate the cause of the failure [* * *].  Patheon will give Client all stability test data and results at Client’s request.  

(e)

Packaging and Artwork.  Patheon will package the Products in accordance with the Specifications.  Client will be responsible for the cost of artwork development.  Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped.  The batch numbers and expiration dates will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs.  Patheon will ensure that the final package for each Product complies with the agreed Specification.   Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products.  Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products.  Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.5.  Patheon's name will not appear on the label or anywhere else on the Products unless: (i) required by any Applicable Laws; or (ii) Patheon consents in writing to the use of its name. At least [* * *] prior to the Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications.  For the avoidance of doubt, the Parties acknowledge and agree that, as between the Parties, Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

(f)

Active Materials and Client-Supplied Components.  At least [* * *] before the scheduled production date (such date to be communicated to Client by Patheon), Client will deliver the Active Materials and any Client-Supplied Components to [* * *], at no cost to Patheon, with any VAT paid by Client, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date.  If the Active Materials and/or Client-Supplied Components are not received [* * *] before the scheduled production date, Patheon may delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components.  But if Patheon is unable, despite using commercially reasonable efforts, to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may delay the shipment until a later date as agreed to by the Parties.  All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material Specifications. For Active Materials or Client-Supplied Components which may be subject to import or export, Client agrees that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism.  On the date of shipment, the API or Client-Supplied Components will conform to their specifications that Client has given to Patheon and the API and Client-Supplied

Components will be adequately contained, packaged, and labeled and will conform to the affirmations of fact on the container.

(g)

Bill Back Items.  The Bill Back Items will be mutually agreed by the Parties and will be charged to Client at [* * *].

(h)

Validation Activities (if applicable).  Upon Client’s request, Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products.  The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement.

(i)

Additional Services.  If Client requests services other than those expressly set forth herein or in any Product Agreement (such as qualification of a new packaging configuration or shipping studies, or validation of alternative batch sizes), Patheon will provide a good faith and reasonable written quote (based on Patheon’s then-current commercial rates for such services) of the fee for the additional services and Client will advise Patheon whether it wishes to have the additional services performed by Patheon. The scope of work and fees will be set forth in a separate agreement signed by the Parties.  The terms and conditions of this Agreement will apply to these services.

(a)

Reporting.  Patheon will give Client a quarterly inventory report of the Active Materials held by Patheon using the inventory report form set out in Exhibit B, which will contain the following information for the Calendar Quarter:

Quantity Converted during the Yearx100%

(b)

Shortfall Calculation.  If the Actual Annual Yield falls more than [* * *] below the respective Target Yield in a Year, then the shortfall for the Year (the “Shortfall”) will be calculated as follows:

(c)

Surplus Calculation.  If the Actual Annual Yield is more than the respective Target Yield in a Year, then the surplus for that Year (the "Surplus") will be determined based on the following calculation:

(d)

Credits

(i)

Shortfall Credit.  If there is a Shortfall for a Product in a Year, then Patheon will credit Client’s account for the amount of the Shortfall not later than 60 days after the end of each Year.

(ii)

Surplus Credit.  If there is a Surplus for a Product in a Year, then Patheon will be entitled to apply the amount of the Surplus as a credit against any Shortfall for that Product which may occur in the next Year.  If there is no Shortfall in the next Year the Surplus credit will expire.

(e)

Maximum Credit.  Except as set forth in Section 10.2(b), Patheon's liability for Active Materials calculated in accordance with this Section 2.2 for any Product in a Year will not exceed, in the aggregate, [* * *].

(f)

[* * *]  

(a)

Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement.  Title to the Active Materials will at all times remain the property of Client.  Any

Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services for Client. [* * *]

(b)

If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon shall agree, pending an agreed-upon scope of work as discussed below, to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The Parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing Specifications; (ii) manufacture of an experimental batch of Product that will be placed on three months accelerated stability; and (iii) manufacture of three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale).

(c)

Patheon will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. [* * *]

(a)

Manufacturing and Stability Testing Costs. Patheon may [* * *] unless the Parties otherwise agree in writing. [* * *]

(b)

Component Costs. If Patheon incurs an increase in excess of [* * *] average Component costs during the Year, it may increase the Price for the next Year by written notice to Client to reflect such increase in additional Component costs to the extent such Price had

not already been adjusted to account for such increase pursuant to Section 4.4(a), such notice to be given within sixty (60) days of the beginning of such next Year. Patheon will give Client, along with such notice, information about the increase in average Component costs which will be applied to the calculation of the Price for the next Year to reasonably demonstrate that the Price increase is justified.  If Client reasonably and in good faith disputes such increase, [* * *].  If Patheon incurs a decrease in excess of [* * *] in average Component costs during the Year, it shall likewise decrease the Price for the next Year by such amount by written notice to Client within thirty (30) days of the beginning of such next Year.

(c)

Pricing Basis.  Client acknowledges that the Price in any Year is quoted based upon [* * *].

(d)

Tier Pricing (if applicable). The pricing in Schedule B of a Product Agreement is set forth in Annual Volume tiers based upon Client’s volume forecasts under Section 5.1.  Client will be invoiced during the Year for the unit price set forth in the Annual Volume tier based on the [* * *] provided in September of the previous Year.  Within 30 days after the end of each Year or of the termination of the Agreement, Patheon will send Client a reconciliation of the actual volume of Product ordered by Client during the Year with the pricing tiers.  If Client has overpaid during the Year, Patheon will issue a credit to Client for the amount of the overpayment within 60 days after the end of the Year or will issue payment to Client for the overpayment within 60 days after the termination of the Agreement.  If Client has underpaid during the Year, Patheon will issue an invoice to Client under Section 5.5 for the amount of the underpayment within 60 days after the end of the Year or termination of the Agreement.  If Client disagrees with the reconciliation, the Parties will work in good faith to resolve the disagreement amicably. If the Parties are unable to resolve the disagreement within 30 days, the matter will be handled under Section 12.1.  For avoidance of doubt, this Section 4.2(d) [* * *].

(e)

For all Price adjustments under this Section 4.2, Patheon will deliver to Client on or about October 1 but no later than December 1 of each Year a revised Schedule B to the Product Agreement to be effective for Product delivered on or after the first day of the next Year. If in any Year Patheon would have been entitled to increase the Price based on any of the provisions of this Section 4.2 but Patheon did not exercise its right to do so, [* * *].

(f)

For a Price adjustment under this Section 4.2 Patheon will deliver to Client a revised Schedule B to the Product Agreement and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price adjustment is justified.  Patheon will have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers but will use commercially reasonable efforts to obtain consent from its suppliers to deliver such documentation if relevant.

(g)

Adjustments Due to Currency Fluctuations.  If the Parties agree in this Product Agreement to invoice in a currency other than the local currency for the Manufacturing Site, [* * *].

(a)

Extraordinary Increases in Component Costs.  If, at any time, market conditions result in Patheon's cost of Components being materially greater than normal forecasted increases, then [* * *].  Changes materially greater than normal forecasted increases will have occurred if: (i) the cost of a Component increases by [* * *] of the cost for that Component upon which the most recent Price or fee quote was based; or (ii) the aggregate cost for all Components required to manufacture a Product increases by [* * *] of the total Component costs for the Product upon which the most recent fee quote was based.  If Component costs have been previously adjusted to reflect an increase in the cost of one or more Components, the adjustments set out in (i) and (ii) above will operate based on the last cost adjustment for the Components.

(b)

For a Price adjustment under this Section 4.4, Patheon will deliver to Client a revised Schedule B to the Product Agreement and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price adjustment is justified.  Patheon will have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers but will use commercially reasonable efforts to obtain consent from its suppliers to deliver such documentation if relevant. The revised Price will be effective for any Product delivered on or after the first day of the month [* * *] provided that in the event that the material increase in Component cost(s) is no longer applicable, the Price shall be adjusted downwards to reflect such and Patheon will promptly deliver a revised Schedule B to the Product Agreement with such revised Price.

(a)

Long Term Forecast.  When each Product Agreement is executed, Client will give Patheon a non-binding [* * *] forecast of Client’s volume requirements for the Product for each Year during the term of the Product Agreement (the “Long Term Forecast”).  The Long Term Forecast will thereafter be updated every [* * *] during the Initial Product Term.  If Patheon is unable to accommodate any portion of the Long Term Forecast, it will notify Client and the Parties will agree on any revisions to the forecast.

(b)

Rolling [* * *] Forecast.  When each Product Agreement is executed, Client will give Patheon a non-binding [* * *] forecast of the volume of Product that Client expects to order in the first [* * *] of commercial manufacture of the Product.  This forecast will then be updated by Client on or before [* * *] on a rolling forward basis. Client will update the forecast forthwith if it determines that the volumes estimated in the most recent forecast have changed by more than [* * *]. The most recent [* * *] forecast will prevail.  These forecasts should be reasonably consistent with the Long Term Forecast.  

(c)

Firm Orders.  On a rolling basis during the term of the Product Agreement, Client will issue an updated [* * *] on or before [* * *]. This forecast will start on the first day of the next month. Unless otherwise agreed in the Product Agreement, the first [* * *] of this updated forecast will be considered binding firm orders.  For the avoidance of doubt, Patheon shall maintain capacity sufficient for Patheon to manufacture and supply the Product in accordance with the first [* * *] of the then-current rolling [* * *] forecast.  Concurrent with the [* * *] forecast, Client will issue a new firm written order in the form of a purchase order (“Firm Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of the Products. The Delivery Date will not be less than [* * *] following the date that such purchase order is received. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products.  The quantities of Products ordered in those written orders will be firm and binding on Client and may not be reduced by Client.  Expedited Firm Orders will be subject to additional fees.  

(d)

Acceptance of Firm Order. Patheon will accept Firm Orders by sending an acknowledgement to Client within [* * *] of its receipt of the Firm Order.  The acknowledgement will include, subject to confirmation from Client, the Delivery Date for the Product ordered or delivery month for any Firm Orders that do not relate to the first [* * *] of the [* * *] forecast. The Delivery Date may be amended by agreement of the Parties or as set forth in Section 2.1(f).  If Patheon fails to acknowledge receipt of a Firm Order within the [* * *] period, the Firm Order will be deemed to have been accepted by Patheon.  Patheon shall notify Client as soon as is reasonably practicable (and in any event not later than [* * *] from the date Patheon becomes aware) of any event which materially impacts Patheon’s ability to supply Product in accordance with a Firm Order and Patheon will consider in good faith any reasonable suggestion of Client to mitigate the delay.

(e)

Cancellation of a Firm Order.  If Client cancels a Firm Order, [* * *].

(f)

Zero Volume Forecast. If, at any time following commercial launch of the Product, Client forecasts, under Section 5.1(c), zero volume for [* * *] during the term of a Product Agreement (the “Zero Forecast Period”), then [* * *].

(g)

Controlled Substance Quota Requirements (if applicable).  Client will give Patheon the information set forth below for obtaining any required DEA or equivalent agency quotas needed to perform the Manufacturing Services.  Patheon will be responsible for routine management of DEA quota information in accordance with DEA regulations. Patheon and Client will cooperate to communicate the information and to assist each other in DEA information requirements related to the Product as follows: (i) as of [* * *] of each Year for the applicable Product, Client will provide to Patheon the next Year’s annual quota requirements for the Product; (ii) as of [* * *] of each Year, Client will provide to Patheon any changes to the next Year’s quota requirements; (iii) Client will pro-actively

communicate any changes to the quota requirements for the then-current Year in sufficient time to allow Patheon to file and finalize DEA filings supporting the changes; (iv) upon Patheon receiving the necessary forecast information from Client in order to request additional quota, Patheon will submit to the DEA, on a timely basis, all filings necessary to obtain DEA or equivalent agency quotas for Active Materials and will use commercially reasonable efforts to secure sufficient quota from the DEA so as to achieve Delivery Dates for Product as set forth in applicable Firm Orders and forecasts submitted to Patheon by Client or its designee; and (v) Patheon will not be responsible for DEA’s refusal or failure to grant sufficient quota for reasons beyond the reasonable control of Patheon.

(a)

Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted under Section 5.1(c) in ordering the Components (other than Client-Supplied Components) required to meet the Firm Orders.  In addition, Client understands that to ensure an orderly supply of the Components, Patheon may want to purchase the Components in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(c) or to meet the production requirements of any longer period agreed to by Patheon and Client.  Accordingly, Client authorizes Patheon to purchase Components to satisfy the Manufacturing Services requirements for Products for the first [* * *] contemplated in the most recent forecast given by Client under Section 5.1(c).  Patheon may make other purchases of Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the Parties.  Client will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon.  

(b)

Patheon will notify Client if there are any Components ordered by Patheon under Firm Orders or under Section 5.2(a) that, despite being purchased with a reasonable shelf life remaining, have expired or are rendered obsolete due to changes in artwork or applicable regulations during the period (collectively, “Obsolete Stock”). Within [* * *] of such notification, Client may request to take possession of such Obsolete Stock and if such request is not made in [* * *], Patheon shall be permitted to destroy such Obsolete Stock.  [* * *]

(c)

If Client fails to take possession or arrange for the destruction of non-expired Components within [* * *] of purchase or, in the case of the delivery of conforming finished Product not accepted by Client within [* * *] of manufacture, Client will pay Patheon [* * *] thereafter for storing the Components or finished Product.  Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at [* * *].  Storage fees are subject to a one pallet minimum charge per month.  [* * *]

(a)

Product Claims.  Client has the right to reject any portion of any shipment of Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, without invalidating any remainder of the shipment.  Client will inspect the Product manufactured by Patheon upon receipt and will give Patheon written notice (a “Deficiency Notice”) of all claims for Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, within [* * *].  If Client fails to give Patheon the Deficiency Notice within the applicable [* * *] period, then the delivery will be deemed to have been accepted by Client on the [* * *].  Patheon will have no liability for any deficiency for which it has not received notice within the applicable [* * *] period.

(b)

Determination of Deficiency.  Upon receipt of a Deficiency Notice, Patheon will have [* * *] to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice.  If Client and Patheon fail to agree within [* * *] after Patheon's notice to Client as

to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, the Parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both Parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process-related, representatives from both Parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined.  If, after the joint testing or investigation has been performed, the Parties still cannot agree on the root cause, executives from both Parties will meet and use good faith efforts to resolve the deficiency and liability issues.  If the Parties’ executives are unable to resolve the dispute [* * *], the dispute will be handled as a Technical Dispute under Section 12.2.

(c)

Shortages and Price Disputes.  Claims for shortages in the amount of Product shipped by Patheon or a Price dispute will be initially dealt with by reasonable agreement of the Parties and any matter on which the Parties cannot agree will be handled as a dispute under Section 12.1. [* * *].

(d)

Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon.  If after a full investigation as set forth in Section 6.1(b), it is determined that Patheon manufactured Product in accordance with Specifications, Applicable Law and cGMPs (including the agreed upon process specifications, the batch production record, and Patheon’s standard operating procedures for manufacturing), and a batch or portion of batch of Product does not meet a finished Product Specification, [* * *]. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.2(a).

(a)

Records and Notice.  Patheon and Client will each maintain records necessary to permit a Recall of any Product delivered to Client or customers of Client.  Each Party will promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product.  Upon receiving this notice or upon this discovery, each Party will stop making any further shipments of any Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary.  The decision to initiate a Recall or to take some other corrective action, if any, will be made and implemented by Client in its sole discretion.  “Recall” will mean any action (i) by Client to recover title to or possession of quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); (ii) by any Regulatory Authorities to detain or destroy any of

the Product; or (iii) by either Party to refrain from selling or shipping quantities of the Product to third parties which would be subject to an action described in clause (i) or (ii) of this sentence if sold or shipped.  

(b)

Recalls.  If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all cGMPs and Applicable Laws.

(c)

Product Returns.  Client will have the responsibility for handling customer returns of the Product.  Patheon will give Client any assistance that Client may reasonably require to handle the returns.

(a)

Defective Product.  If Client rejects Product under Section 6.1 and the deficiency is determined to have arisen from [* * *], Patheon will credit Client’s account for Patheon’s invoice price for the defective Product.  If Client previously paid for the defective Product, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Product; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Product with conforming Product [* * *].  For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product [* * *].

(b)

Recalled Product.  If a Recall or return results from, or arises out of, [* * *]

(c)

Other than as set forth in Section 6.3(a) or Section 6.3(b), [* * *]  

(d)

Notwithstanding anything to the contrary in this Agreement, Patheon will only be required to replace or refund any batch or portion of a batch of Recalled Product and will only be liable for Active Material contained therein to the extent the Product is unsold, returned, destroyed or otherwise disposed of in accordance with the terms of this Agreement.  The quantity of Active Material contained in any rejected, Recalled or otherwise non-conforming Product will be included in the Quantity Dispensed but not in the Quantity Converted for purposes of calculating the Shortfall in Section 2.2(b).

(a)

Regulatory Authority.  Client will have the sole responsibility at Client’s expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the

commercial manufacture, distribution and sale of the Products (“Regulatory Approval”) [* * *].  Patheon will assist Client, to the extent consistent with Patheon’s obligations under this agreement so as to obtain Regulatory Authority approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.

(b)

Verification of Data.  Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data.  The Parties agree that Patheon shall have [* * *].  Any review by Patheon under this Section 7.8(b) shall be at no cost to Client.

(c)

Verification of CTD.  Prior to filing with any Regulatory Authority any documentation which is or is equivalent to the Quality Module (Drug Product Section) of the Common Technical Document (all such documentation herein referred to as “CTD”) related to any Marketing Authorization, such as a US New Drug Application, US Abbreviated New Drug Application, US Biologics License Application, or EU Marketing Authorization Application, Client will give Patheon a copy of the CTD in order for Patheon to verify that the CTD accurately describes the validation or scale-up work that Patheon has performed and the manufacturing processes that Patheon will perform under this Agreement.  The Parties agree that Patheon shall have [* * *].  Client will give Patheon copies of all relevant filings at the time of submission which contain CTD information regarding the Product.  Any review by Patheon under this Section 7.8(c) shall be at no cost to Client.  

(d)

Deficiencies.  If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies.  The Parties will work together in good faith to have any Deficiencies resolved prior to the date of filing of the relevant application and in any event before any PAI or before the Product is placed on the market if a PAI is not performed.

(e)

Client Responsibility.  In reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon.  Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority.  Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by Client.

(f)

Inspection by Regulatory Authorities.  If Client does not give Patheon the documents requested under subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized,  Patheon may, in its sole discretion, delay or postpone any inspection by the

Regulatory Authority until Patheon has reviewed the requested documents; provided that such review shall take no longer than [* * *]; and until any deficiencies in the documentation relating to Patheon’s work are remedied. Any review by Patheon under this Section 7.8(f) shall be at no cost to Client.

(g)

Pharmacovigilance.  Client will be responsible, at its expense, for all pharmacovigilance obligations for the Products pursuant to Applicable Laws.  Unless required by Applicable Law, neither Party will be obliged to exchange with the other Party any information or data which it compiles pursuant to pharmacovigilance obligations or activities.

(h)

No Patheon Responsibility.  Subject to Section 7.8(e), Patheon will not assume any responsibility for the accuracy of any application for Regulatory Approval.  If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon reasonably considers unexpected and extraordinary and such fees, costs or activities are not otherwise contemplated by this Agreement, then Patheon will notify Client in writing and the Parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing.  If, despite reasonable, good faith negotiations between the Parties, agreement cannot be reached as to fee/cost allocation, [* * *].

(a)

Either Party at its sole option may terminate this Agreement or a Product Agreement upon written notice where the other Party has failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement or the Product Agreement within [* * *] following receipt of a written notice (the "Remediation Period") of the breach from the aggrieved Party that expressly states that it is a notice under this Section 8.2(a) (a "Breach Notice"), [* * *]. The termination of a Product Agreement under this Section 8.2(a) will not affect this Agreement or any other Product Agreements where there has been no material breach of the other Product Agreements.  Any termination under this Section 8.2(a) shall be subject to the provisions of Section 8.3(a)(v).

(b)

Either Party at its sole option may immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other Party if: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other Party; or (iii) this Agreement or a Product Agreement is assigned by the other Party for the benefit of creditors.

(c)

Client may terminate a Product Agreement upon [* * *] prior written notice if any Authority takes any action, or raises any objection, that prevents Client from importing, exporting, purchasing, or selling the Product.  [* * *]

(d)

Client may terminate a Product Agreement upon [* * *] prior written notice if it intends to no longer order Manufacturing Services for a Product due to the Product's discontinuance in the market other than as set forth in Section 8.2(c).

(e)

Patheon may terminate this Agreement or a Product Agreement upon 12 months' prior written notice if Client assigns under Section 13.7 any of its rights under this Agreement or a Product Agreement to an assignee that, in the reasonable good faith opinion of Patheon, is: [* * *].  Notwithstanding the foregoing, Patheon may not terminate this Agreement or any Product Agreement if, during such 12-month notice period, [* * *]

(a)

If a Product Agreement is completed, expires, or is terminated in whole or in part for any reason, then:

(i)

Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement (i.e. that are

conforming Products) that are not unmarketable due to the failure of Patheon or the Manufacturing Site to comply with Specifications, Applicable Laws or cGMPs under a Firm Order [* * *];

(ii)

Unless Client terminates this Agreement pursuant to [* * *], Client will purchase, [* * *] all cGMP-compliant Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2. [* * *]  

(iii)

Unless Client terminates this Agreement pursuant to [* * *], Client will satisfy the purchase price payable under Patheon's orders with suppliers of cGMP-compliant Components, if the supplier orders are not able to be cancelled or reduced and were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2, and all such Components for which Client has paid the purchase price shall be transferred to Client. [* * *]

(iv)

Patheon shall provide reasonable support and documentation to Client to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer. [* * *];

(v)

In the event that a technology transfer to a third party manufacturer is required on Client’s proper notice of termination of this Agreement, this Agreement shall be extended for a reasonable period to cover the technology transfer and to give the third party manufacturer sufficient time to manufacture Product of sufficient quantity and quality to replace Patheon’s supply.  For the avoidance of doubt, all the terms of this Agreement shall continue to apply during this period and all activities must be completed promptly by Client and its third party manufacturer.  Client must give Patheon accurate monthly written updates on the duration of the extension, which cannot exceed [* * *]; and

(vi)

Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [* * *], all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“Client Property”).  If Client fails to remove Client Property within [* * *] following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [* * *] thereafter for storing Client Property and will assume any third party storage charges invoiced to Patheon regarding Client Property.  Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement. If Client fails to remove Client Property within [* * *] following the completion, termination, or expiration of the Product Agreement, Client will assume all risk of loss or damage to the stored

Client Property and it will be Client’s responsibility to have appropriate insurance coverage in place for this risk. If Client asks Patheon to destroy any Client Property, Client will be responsible for the cost of destruction.

(b)

Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the Parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement.  For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the Parties under Sections 1.3 (Definitions) through 1.6 (Singular Terms) (solely to the extent necessary to give meaning to the other surviving sections), Section 5.5 (Invoices and Payment), ARTICLE 6 (Product Claims and Recalls), Section 7.3 (Records and Accounting by Patheon), Section 7.4 (Inspection), this Section 8.3 (Obligations on Termination), ARTICLE 10 (Remedies and Indemnities), ARTICLE 11 (Confidentiality), ARTICLE 12 (Dispute Resolution) and ARTICLE 13 (Miscellaneous), all of which survive any completion, termination or expiration.

(a)

the Specifications for each of the Products are its or its Affiliate's property and that Client may lawfully disclose the Specifications to Patheon;

(b)

any Client Intellectual Property used by Patheon in performing the Manufacturing Services according to the Specifications (A) is owned or controlled by Client to the extent necessary to give Patheon the right to use such Client Intellectual Property as contemplated under this Agreement, (B) to Client’s knowledge, [* * *] and (C) to Client’s knowledge, [* * *]; provided that, notwithstanding anything to the contrary in this Agreement, Client shall not be deemed to have breached this Section 9.2(b) in the event that such breach [* * *];

(c)

as of the Effective Date, Client has received no written notification of any actions or other legal proceedings involving Client that claim the infringement of Third Party Rights by the [* * *];

(d)

the Specifications for all Products conform to all applicable cGMPs and Applicable Laws; and

(e)

Client will comply with all Applicable Law relating to its activities contemplated under this Agreement including, without limitation, the sale and distribution of Products for human consumption in any jurisdiction where the Products are marketed.

(a)

it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, the Quality Agreement and Applicable Laws;

(b)

each Product at the time of delivery to Client shall (i) conform with Specifications, cGMPs and Applicable Laws, (ii) not be adulterated or misbranded within the meaning of the FD&C Act;

(c)

it will allocate reasonably adequate resources to execute its obligations under this Agreement or any Product Agreement on the basis of Client’s reasonable forecasts;

(d)

any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights;

(e)

[* * *];

(f)

it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b);

(g)

it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; and

(h)

[* * *]

(a)

Except as set forth in Section 9.4(b), Client will be solely responsible for obtaining or maintaining, on a timely basis, any permits or other Regulatory Approvals for the Products or the Specifications, including, without limitation, all marketing and post-marketing approvals.

(b)

Patheon will maintain at all relevant times all governmental permits, licenses, approval, and authorities required to enable it to lawfully and properly perform the Manufacturing Services, including any permits or approvals required to conduct such Manufacturing Services at the Manufacturing Site.

(a)

[* * *]

(b)

[* * *]

(c)

[* * *]

(d)

[* * *]

(a)

Patheon agrees to defend and indemnify Client, its Affiliates and their respective directors, officers, employees and agents (“Client Representatives”) against all losses, damages, costs, claims, demands, judgments and liability (including attorneys’ fees and expenses reasonably incurred) to, from and in favour of third parties (other than Affiliates) for (a) any claim of personal injury or property damage to the extent that the injury or damage is the result of [* * *]; (b) infringement by Patheon of any third party Intellectual Property rights arising from the use by Patheon of Patheon Intellectual Property in the performance of the Manufacturing Services except to the extent that Client has an obligation to indemnify any Patheon Representative for such losses, damages, costs, claims, demands, judgments or liability pursuant to Section 10.4.

(b)

If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Patheon in the defense of the claim; and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon's cost and expense. But Patheon shall not be permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Client or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Client, without Client’s prior written consent.

(a)

Client agrees to defend and indemnify Patheon, its Affiliates and their respective directors, officers, employees and agents (“Patheon Representatives”), against all losses, damages, costs, claims, demands, judgments and liability (including attorneys’ fees and expenses reasonably incurred) to, from and in favour of third parties (other than Affiliates) for (i) any assertion that the Client Intellectual Property or the Tufts Technology infringes or misappropriates any Intellectual Property right of a third party or (ii) any personal injury or property damage based on the commercial use, sale or distribution of the Product except to the extent that either (1) Patheon has an obligation to indemnify any Client Representative for such losses, damages, costs, claims, demands, judgments or liability pursuant to Section 10.3 or (2) any losses, damages, costs, claims, demands, judgments or liability are caused by the failure of Patheon to submit complete or accurate information to Client regarding any Client Intellectual Property assigned to Client.

(b)

If a claim occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client to control the defense and settlement of the claim, all at Client's cost and expense. But Client shall not be permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Patheon or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Patheon, without Patheon’s prior written consent.

(a)

is or becomes publicly known through no breach of this Agreement or fault of the Recipient or its Representatives;

(b)

is in the Recipient's possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient's breach of any legal obligation;

(c)

is or becomes known to the Recipient on a non-confidential basis through disclosure by sources, other than the Disclosing Party, having the legal right to disclose the Confidential Information, provided that the other source is not known by the Recipient to be bound by any obligations (contractual, legal, fiduciary, or otherwise) of confidentiality to the Disclosing Party with respect to the Confidential Information;

(d)

is independently developed by the Recipient without use of or reference to the Disclosing Party's Confidential Information as evidenced by Recipient’s written records; or

(e)

is expressly authorized for release by the written authorization of the Disclosing Party.

(a)

For the term of this Agreement, Client hereby grants to Patheon a non-exclusive, paid-up, royalty-free, non-transferable license of Client Intellectual Property solely to perform the Manufacturing Services as set forth under this Agreement, the Product Agreement and the Quality Agreement.

(b)

All Client Intellectual Property will be the exclusive property of Client.  If, at any time before or during the Term, Patheon owns (solely or jointly) any Client Intellectual Property, Patheon agrees to assign and does hereby assign all right, title and interest in and to such Client Intellectual Property to Client.  Patheon shall, and shall cause its Affiliates to, execute and deliver all requested assignments and other documents, and take such other actions as Client may reasonably request at Client’s cost, in order to perfect and enforce Client’s rights in the Client Intellectual Property.  Patheon shall, at Client’s cost and expense, provide all relevant information in its and its Affiliates’ possession and other reasonable assistance to Client so that Client can conduct a timely and accurate analysis of the likelihood that any Client Intellectual Property to be assigned or assigned to Client by Patheon infringes the intellectual property rights of a Third Party.

(c)

All Patheon Intellectual Property will be the exclusive property of Patheon. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive, paid-up, royalty-free

license to use the Patheon Intellectual Property used by Patheon to perform the Manufacturing Services to enable Client itself to manufacture the Product(s). If, at any time before or during the Term, Client owns (solely or jointly) any Patheon Intellectual Property, Client agrees to assign and does hereby assign all right, title and interest in and to such Patheon Intellectual Property to Patheon.  Client shall, and shall cause its Affiliates to, execute and deliver all requested assignments and other documents, and take such other actions as Patheon may reasonably request at Patheon’s cost, in order to perfect and enforce Patheon’s rights in the Patheon Intellectual Property.  [* * *]

(d)

Each Party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions.

(e)

Either Party will give the other Party written notice, as promptly as practicable, of all Inventions arising under this Agreement.  On request, either Party shall provide all reasonably necessary documentation and support (subject to the other Party reimbursing its time and expenses in doing so) to transfer any Intellectual Property belonging to the Party that has ownership of it (in accordance with this Section 13.1) to enable the other Party to register any Inventions. On request from Client, Patheon shall supply with a written summary of all Inventions arising during the performance of the Manufacturing Services which constitute Client Intellectual Property.

13.3.1

To the extent any of the Client Intellectual Property licensed to Patheon under Section 13.1(a) includes any intellectual property or embodiments thereof licensed to Client pursuant to that certain Tufts University License Agreement by and between Client and Tufts University (“Tufts”), dated as of February 1, 1997 (the “Tufts License” and such intellectual property or embodiments thereof, “Tufts Technology”), Patheon acknowledges that the provisions of this Section 13.3.1 shall apply with respect to such Tufts Technology, and Patheon agrees to comply with this Section 13.3.1. Without limiting the generality of Section 13.3.1, the Parties acknowledge and agree that the provisions of Sections 7.1, 8.1, 8.5 and Articles V, XI and XII of the Tufts License shall be binding upon Patheon to the extent Patheon is a sublicensee under the Tufts Agreement and such provisions shall be fully enforceable for all purposes related thereto both by Tufts and Client.

(a)

Patheon agrees that it will not use the name “Tufts University”, or any variant thereof, or identify Tufts or any portion of Tufts, or any inventor of any Tufts Technology, as a party

to the Tufts License or this Agreement, or as a participant in inventing the inventions within the Tufts Technology or creating the Tufts Technology, including, without limitation, any advertising or promotional sales literature, without the prior express written consent of Client, which consent may be withheld or withdrawn by Client in its complete and uncontrolled discretion for any reason whatsoever and at any time or times. Patheon shall impose and enforce the requirements of this Section 13.3.1(a) on its Affiliates.

(b)

Patheon hereby agrees and gives its assurance to Tufts that Patheon will not, unless any required prior authorization is obtained from the U.S. Office of Export Control, re-export directly or indirectly any technical data within the Tufts Technology and will not export directly the Products or such technical data to any country listed on either the Commodity Control List or Militarily-Critical Technologies List.  Tufts makes no representation as to whether any such license is required or, if one is required, as to whether it will be issued by the U.S. Department of Commerce.  In addition to the foregoing export control requirements, Patheon agrees that it and its subsidiaries will comply with all applicable mandatory or permissive patent marking laws, rules, and regulations and comply with all other laws, rules, and regulations of all governmental authorities applicable to any of their activities contemplated by this Agreement, and will comply with all necessary and desirable practices in connection and compliance with safety recommendations of trade associations or governmental authorities.

(c)

Patheon hereby acknowledges and agrees that:

(i)

TUFTS MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED (INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PURPOSE), AND ASSUMES NO RESPONSIBILITIES WHATSOEVER, WITH RESPECT TO THE TUFTS TECHNOLOGY OR THE USE THEREOF, OR THE MANUFACTURE, POSSESSION, USE OR OTHER DISPOSITION BY TUFTS, THE PARTIES OR ANYONE ELSE, OF PRODUCTS OR ANY OTHER PRODUCTS OR SERVICES (INCLUDING, WITHOUT LIMITATION, PRODUCTS MADE BY TUFTS, AND TUFTS SERVICES, THAT ARE OR WERE FURNISHED TO A PARTY AT ANY TIME BEFORE, ON OR AFTER THE EFFECTIVE DATE).  

(ii)

Without limitation of the foregoing generality, nothing contained herein or in any disclosure of the Tufts Technology made by or on behalf of Tufts shall be construed as extending any representation or warranty with respect to the Tufts Technology or Products or the results to be obtained by the use of the Client Intellectual Property or any Products, or that anything made, used, or sold by use of the Tufts Technology or any part thereof, alone or in combination, will be free from infringement of patents of third parties.

(iii)

TUFTS SHALL NOT BE LIABLE TO EITHER PARTY, ITS SUBSIDIARIES OR ANY OTHER PARTY, REGARDLESS OF THE FORM OR THEORY OF ACTION (WHETHER CONTRACT, TORT, INCLUDING NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE), FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR OTHER EXTRAORDINARY DAMAGES ARISING OUT OF THIS AGREEMENT, THE TUFTS TECHNOLOGY, THE PRODUCTS, OR ANY PRODUCTS OR SERVICES FURNISHED OR NOT FURNISHED BY TUFTS, EVEN IF TUFTS HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.  

13.3.2

[* * *]

13.3.3

[* * *]

13.3.4

If a claim is made by [* * *] which falls within the scope of Section 13.3.3, [* * *]

13.3.5

In the event of any expiration or termination of the Tufts License for any reason, Client shall forthwith notify Patheon in writing.  If any Tufts Technology is necessary to perform the Manufacturing Services, Patheon shall cease performing Manufacturing Services under the applicable Product Agreement until an alternative license is put in place by Client to cover Patheon’s activities hereunder or the Parties agree on a manner of performing the Manufacturing Services without the use of Tufts Technology.  [* * *]

(a)

Patheon may not assign this Agreement or any Product Agreement or any of its associated rights or obligations without the written consent of Client, this consent not to be unreasonably withheld.  But Patheon may arrange for Affiliates or subcontractors to perform Manufacturing Services, including specific testing services, under any Product Agreement with the consent of Client; provided, however, that Patheon will remain solely liable to Client for its obligations under this Agreement, and for the obligations of it or the applicable Affiliate of Patheon under the Quality Agreement, if the Manufacturing Services are subcontracted.  Nothing in this Agreement shall prevent Patheon subcontracting work to the Patheon Affiliate responsible for the Manufacturing Site specified as performing the Manufacturing Services in the Product Agreement.

(b)

Subject to Section 8.2(e), Client may assign this Agreement or any Product Agreement or any of its associated rights or obligations without approval from Patheon.  But Client will give Patheon prior written notice of any assignment, any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement or the Product Agreement, and Client will remain liable hereunder.  Any partial assignment will be subject to Patheon’s cost review of the assigned Products. Patheon and Client shall enter into good faith discussions to agree the terms of the assignment document including, without limitation, amended Manufacturing Service fees within a reasonable time, such fees to reflect extra work and costs incurred by Patheon as a result of the partial assignment. Client will reimburse Patheon for any costs incurred by Patheon in connection with the partial assignment including any expenses incurred by Patheon for any due diligence audits in connection with the partial assignment.  Notwithstanding the foregoing, in the event Client delivers a written request to Patheon requesting that Patheon engage in negotiations with a licensee of Client on the terms of a definitive agreement pursuant to which Patheon would manufacture and supply Product to such licensee or its designee, Patheon shall use commercially reasonable good faith efforts to negotiate and execute such agreement using this Agreement and the Product Agreement as the basis for such agreement with any commercially reasonable (as determined by Patheon in its sole discretion) adjustments.

(c)

Notwithstanding the foregoing provisions of this Section 13.7, either Party may assign this Agreement or any Product Agreement to (i) any of its Affiliates or (ii) a successor to or purchaser of all or substantially all of its business, but the assignee must execute an agreement with the non-assigning Party whereby it agrees to be bound hereunder.

(a)

[* * *]

(b)

Notwithstanding Section 13.17(a), 13.17(c) or 13.17(f), Patheon shall be responsible for (i) any taxes or Duties that are recoverable by Patheon or its Affiliates in the ordinary course of business for purchases made by Patheon in the course of providing its Manufacturing Services, such as VAT, (ii) any Tax based on net income or gross income that is imposed on Patheon or its Affiliates by its respective jurisdiction of formulation or incorporation (“Resident Jurisdiction”), or (iii) any Tax based on net income or gross income that is imposed on Patheon or its Affiliates by jurisdictions other than its respective Resident Jurisdiction if this tax is based on a permanent establishment or the location of the conduct of business of Patheon or its Affiliates. However, if Patheon is acting as Client’s buying agent, Patheon will always charge to the Client VAT in the relevant territory in addition to the amount paid by Patheon to supplier.

(c)

Subject to Section 13.17(b), if Client, is required to bear any tax or Duty under this Agreement by any state, federal, provincial or foreign government, including, but not limited to, withholding tax, Client will be responsible for the payment of such tax or Duty and to the extent such payment is required by any governmental authority to be deducted or withheld on payments made to Patheon under this Agreement (except for amounts withheld that are  attributable to backup withholding under Section 3406 of the Internal Revenue Code of 1986, as amended (the “Code”), or any similar provision of state, local or non-U.S. law, or (iv) pursuant to FATCA as defined below (or similar information reporting regimes under non U.S. law)),  the payment due from Client to Patheon to which such deduction or withholding taxes relate shall be grossed up such that the net amounts received by Patheon hereunder after all such payments or withholdings equal the amount to which Patheon is otherwise entitled under this Agreement, as applicable, as if the tax or Duty did not exist. Patheon will not collect an otherwise applicable tax if Client's purchase is exempt from Patheon's collection of the tax and a valid tax exemption

certificate is furnished by Client to Patheon. “FATCA” as used in this Section 13.17(c) refers to Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version thereof or any similar non-U.S. law), any current or future regulations or official interpretations thereof (including any Revenue Ruling, Revenue Procedure, Notice or similar guidance issued by the IRS thereunder as a precondition to relief or exemption from taxes under such provisions), and any intergovernmental agreements and any agreements entered into pursuant to Section 1471(b) of the Code.

(d)

The Parties shall each make reasonable efforts to, and reasonably cooperate with each other to, recover, eliminate or minimize the amount of any such taxes or Duties imposed on or arising from the transactions contemplated in this Agreement at all times in accordance with Applicable Laws and good practice.

(e)

Any Tax that Client pays, or is required to pay, but which Client believes should properly be paid by Patheon pursuant hereto may not be offset against sums due by Client to Patheon whether due pursuant to this Agreement or otherwise.

(f)

[* * *]

(g)

If Patheon (i) receives any refund (whether by payment, offset, credit or otherwise) or (ii) utilizes any overpayment of taxes to reduce a tax that would otherwise have been the responsibility of Patheon, in each case, with respect to taxes that are borne by Client pursuant to this Agreement, then Patheon will promptly pay, or cause to be paid, to Client the amount of such refund or overpayment (including, for the avoidance of doubt, any interest or other amounts received with respect to such refund or overpayment), net of any additional taxes Patheon incurs or will incur as a result of the receipt of such refund or such overpayment.

(a)

Composition. Patheon and Client will designate a Supply and Quality Committee with an equal number of representatives from each Party to serve as a coordinating body for all activities under this Agreement, including each Product Agreement and the Quality Agreement. The Supply and Quality Committee shall be comprised of an equal number of representatives of each Party.  Each Party shall appoint its respective representatives to the Supply and Quality Committee within [* * *] days of agreement between the Parties on the establishment of the Supply and Quality Committee, and each Party, from time to time, may substitute [* * *] or more of its representatives, in its sole discretion, effective upon notice to the other Party of such change.  All Supply and Quality Committee representatives shall have appropriate expertise, seniority, decision-making authority and relevant expertise in matters related to the manufacturing and supply of the Product.  

(b)

Meetings.  The Supply and Quality Committee shall meet as necessary to carry out its duties under this Section 13.20, [* * *].  The Supply and Quality Committee shall meet in-person at Client or Patheon, or, alternatively, by means of teleconference, videoconference or other similar communications equipment.

(c)

Supply and Quality Committee Responsibilities.  The Supply and Quality Committee shall provide a forum for the discussion, coordination and review of all activities under this Agreement (including under any Product Agreement and the Quality Agreement), and shall in particular have responsibility for the following: (a) reviewing key metrics for the Product’s production and quality, and reviewing and monitoring any required remediation with respect to production and quality for the Product; (b) reviewing Patheon’s capacity and short-term and long-term planning for clinical and commercial supply of the Product, including anticipating any capacity shortfalls; and (c) establishing resource priorities and resolving resource conflicts.

(d)

Decision-Making. All of each Party’s representatives on the Supply and Quality Committee shall collectively have [* * *] with respect to decisions before the Supply and Quality Committee.  All decisions of the Supply and Quality Committee must be made by unanimous consent, which shall be documented in written minutes of the Supply and Quality Committee and signed by a representative of each Party.

By:

/s/ Andrew Robinson

Name:

Andrew Robinson

Title:

Director

Date:

7/28/17

By:

/s/ William M. Haskel

Name:

William M. Haskel

Title:

SVP, General Counsel and Corporate Secretary

Date:

7/28/17

1.

Product List and Specifications (See Schedule A attached hereto)

2.

Minimum Order Quantity, Annual Volume, and Price (See Schedule B attached hereto)

3.

Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto)

4.

Active Materials[* * *] (See Schedule D attached hereto)

5.

[* * *]

6.

Territory: (insert the description of the Territory here)

7.

Manufacturing Site: (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)

8.

Inflation Index: pursuant to Section 4.2(a) of the Master Agreement, the inflation index is [     ]   [for US and Puerto Rico, the Producer Price Index pcu32541235412 for Pharmaceutical Preparation Manufacturing (“PPI”) published by the United States Department of Labor, Bureau of Labor Statistics] [for Italy, the Consumer Price Index, published by ISTAT.  This index is set forth at the following web address: http://www.istat.it/salastampa/comunicati/in_calendario/precon/20110114_00/] [France] [France – TBC]

9.

Currency: (if applicable under Section 1.4 of the Master Agreement)

10.

Initial Product Term: (per Section 8.1 of the Master Agreement) from the Effective Date until December 31, 20__

11.

Notices: (if applicable under Section 13.10 of the Master Agreement)

12.

Other Modifications to the Master Agreement: (if applicable under Section 1.2 of the Master Agreement)

13.

[* * *]

[Insert Price Table]

•

[* * *]

•

[* * *]

Active Materials

Supplier

•

•

•

•

(a)

Timing.  The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the Parties and that he issues the authorizations to the Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [* * *] (or another date as the Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.

(b)

Disclosure of Evidence.  The Parties undertake one to the other to give to any expert all the evidence and information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within [* * *] of a written request from the relevant expert to do so.  All disclosures to such expert shall be subject to confidentiality obligations at least as strict as those in the Master Agreement.

(c)

Advisors.  Each Party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the Parties will co-operate and seek to narrow and limit the issues to be determined.

(d)

Appointment of New Expert.  If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either Party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue between the Parties except if the existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn.

(e)

Final and Binding.  The determination of the expert will, except for fraud or manifest error, be final and binding upon the Parties.

(f)

Costs.  Each Party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the Parties.

RE:

Active Materials quarterly inventory report under Section 2.2(a) of the Master Manufacturing Services Agreement dated • (the "Agreement")

Reporting quarter:

Active Materials on hand

at beginning of quarter:

kg

(A)

Active Materials on hand

at end of quarter:

kg

(B)

Quantity Received during quarter:

kg

(C)

Quantity Dispensed¹ during quarter:

kg

(A + C – B)

Quantity Converted during quarter:

kg

(total Active Materials in Products produced

and not rejected, recalled or returned or in work-in-process)

PATHEON UK LIMITED

DATE:

[or applicable Patheon Affiliate]

Per:

Name:

Title:

14.

Product List and Specifications (See Schedule A attached hereto).

15.

Minimum Order Quantity Annual Volumes and Price (See Schedule B attached hereto).

16.

Annual Stability Testing (See Schedule C attached hereto).

17.

Active Materials[* * *] (See Schedule D attached hereto).

18.

[* * *]

19.

Territory: [* * *]

20.

Manufacturing Site: [* * *]

21.

Inflation Index: the inflation index is, the consumer Price Index, published by ISTAT. This index is set forth at the following web address: http://dati.istate.it/?lang=en

22.

Currency: US Dollars

23.

[* * *]

24.

Initial Product Term: per Section 8.1 of the Master Agreement, from the Effective Date until December 31, 2022.

25.

Notices: As stated in Section 13.10 of the Master Agreement

26.

Other Modifications to the Master Agreement:

By:

/s/ Andrew Robinson

Name:

Andrew Robinson

Title:

Director

Date:

7/28/17

By:

/s/ William M. Haskel

Name:

William M. Haskel

Title:

SVP, General Counsel and Corporate Secretary

Date:

7/27/17

Product

Vial Size

Fill Volume

Lyo Cycle Duration

Packaging Configuration

PTK0796 lyophilized vials

[* * *]

[* * *]

[* * *]

[* * *]

Active Materials

Supplier

ptk0796