Document:

Exhibit 10.5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

ZYDIS® DEVELOPMENT AND LICENSE AGREEMENT
 (Riluzole)

 

This Zydis® Development and License Agreement (“Agreement”) is made as of this 9th day of March, 2015 (“Effective Date”), by and between Biohaven Pharmaceutical Holding Company Ltd., a corporation duly formed under the laws of the British Virgin Islands (“Client”), and Catalent U.K. Swindon Zydis Limited, a company organized under the laws of Scotland (registered number SC070961), with a place of business at Frankland Road, Blagrove, Swindon, Wiltshire, UK SN5 8YG (“Catalent”) and Client are sometimes referred to in this Agreement as the “Parties” and individually as a “Party”.

 

RECITALS

 

A.                                    Client is a pharmaceutical company that develops, markets and sells pharmaceutical products, including the Drug (as defined below);

 

B.                                    Catalent and its Affiliates have developed proprietary drug delivery technology for the manufacture of the Orally Disintegrating Tablets (“ODT”) including the patented Zydis® Fast Dissolving Dosage Form (“Zydis”) for the administration of pharmaceutical drugs (collectively, along with the Zydis Patents and all data, results and information relating to Zydis and the Zydis Patents (whether produced prior to or after the Effective Date), the “Zydis Technology”);

 

C.                                    A feasibility study by Catalent pursuant to that certain Biohaven Riluzole Zydis® Feasibility Programme dated March 5, 2014 (the “Evaluation Agreement”) has been initiated to determine the likelihood of compatibility between the Zydis Technology and the Drug; and

 

D.                                    Client desires to engage Catalent to conduct the Development Program (as defined herein), upon satisfactory results of the feasibility studies under the Evaluation Agreement, to develop additional data for the regulatory approval and commercialization of a Zydis Formulation, and Catalent desires to provide such services, all pursuant to the terms and conditions set forth in this Agreement.

 

THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the Parties agree as follows:

 

ARTICLE 1
 DEFINITIONS

 

The following terms have the following meanings in this Agreement:

 

1.1                               “Action” means any legal action, claim, suit or proceeding, including any declaratory judgment action.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.2                               “Affiliate(s)” means, with respect to Client or any third party, any corporation, firm, partnership or other entity that controls, is controlled by or is under common control with such entity; and with respect to Catalent, Catalent Pharma Solutions, Inc. and any corporation, firm, partnership or other entity controlled by it.  For purposes of this definition, “control” means the ownership of at least 50% of the voting share capital of an entity or any other comparable equity or ownership interest.

 

1.3                               “Agreement” has the meaning set forth in the introductory paragraph, and includes all its Attachments and other appendices (all of which are incorporated herein by reference) and any amendments to any of the foregoing made as provided herein or therein.

 

1.4                               “Applicable Laws” means, with respect to Client, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which Drug or Zydis Formulation is produced, marketed, distributed, used or sold; and with respect to Catalent, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Catalent performs services; provided, that cGMP shall not constitute Applicable Laws except to the extent expressly stated in the Development Program.

 

1.5                               “Catalent” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.  Catalent shall have the right to cause any of its Affiliates to perform any of its obligations hereunder, and Client shall accept such performance as if it were performance by Catalent.

 

1.6                               “Catalent Indemnitees” has the meaning set forth in Section 8.2.

 

1.7                               “Catalent IP” has the meaning set forth in Section 6.1.

 

1.8                               “cGMP” current Good Manufacturing Practices promulgated by the Regulatory Authorities in the jurisdictions included in Applicable Laws (as applicable to Client and Catalent respectively).  In the United States, this includes 21 C.F.R. Parts 210 and 211, as amended; and in the European Union, this includes 2003/94/EEC Directive (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended, if and as implemented in the relevant constituent country.

 

1.9                               “Change Order” has the meaning set forth in Section 2.3.

 

1.10                        “Client” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.

 

1.11                        “Client-supplied Materials” means any materials to be supplied by or on behalf of Client to Catalent for Catalent to conduct the Development Program, as provided in the Development Program, including Drug and reference standards.

 

1.12                        “Client Indemnitees” has the meaning set forth in Section 8.1.

 

1.13                        “Client Inventions” has the meaning set forth in Section 6.1.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.14                        “Client IP” has the meaning set forth in Section 6.1.

 

1.15                        “Commencement Date” has the meaning set forth in the Evaluation Agreement, as in effect on the date hereof.

 

1.16                        “Confidential Information” has the meaning set forth in Section 5.1.

 

1.17                        “CPR” has the meaning set forth in Section 13.10.

 

1.18                        “DEA” means the U.S. Drug Enforcement Agency or any successor agency thereto.

 

1.19                        “Development Batch” has the meaning set forth in Section 4.6.

 

1.20                        “Development Program” has the meaning set forth in Section 2.1.

 

1.21                        “Discloser” has the meaning set forth in Section 5.1.

 

1.22                        “Drug” means the active pharmaceutical compound riluzole, riluzole prodrugs and [* * *] of riluzole and riluzole prodrugs.

 

1.23                        “Effective Date” has the meaning set forth in the introductory paragraph.

 

1.24                        “EMA” means the European Medicines Agency or any successor agency thereto.

 

1.25                        “Evaluation Agreement” has the meaning set forth in Recital C.

 

1.26                        “Facility” means Catalent’s facility located in Swindon, UK, or such other facility as agreed by the Parties.

 

1.27                        “FDA” means the U.S. Food and Drug Administration or any successor agency thereto.

 

1.28                        “Field” means medical disorders treatable by the Drug in humans.

 

1.29                        “First Launch Date” means the date of Launch for the first Product developed hereunder.

 

1.30                        “GAAP” means U.S. generally accepted accounting principles, consistently applied over the relevant period.

 

1.31                        “Intellectual Property” has the meaning set forth in Section 6.1.

 

1.32                        “Inventions” has the meaning set forth in Section 6.1.

 

1.33                        “Launch” means, with respect to each Product developed hereunder, the first commercial sale of such Product by or on behalf of Client or Client’s permitted sublicensees in the Territory after receipt of Regulatory Approval and, if required, Pricing Approval.

 

1.34                        “Losses” has the meaning set forth in Section 8.1.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

3

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.35                        “Net Sales” means, for the measured period, the gross invoiced amounts for Products sold or commercially disposed of for value by Client or its permitted sublicensees (including its Affiliates) or distributors, less the following:

 

A.                                    customary trade allowances, discounts [* * *];

 

B.                                    credits or allowances given or made for rejection, recall or return of previously sold Product actually taken or allowed;

 

C.                                    [* * *] payments and rebates [* * *];

 

D.                                    [* * *];

 

E.                                     sales taxes, value-added taxes, excise or use taxes, tariffs, duties and customs fees and other taxes, [* * *];

 

F.                                      freight, insurance, inventory and other transportation expenses [* * *];

 

G.                                    [* * *]; and

 

deductions for [* * *].

 

In addition, Net Sales shall include (A) [* * *] and (B) [* * *].

 

Sales of Products between Client and its permitted sublicensees (including its Affiliates) shall be disregarded for the purposes of calculating Net Sales, and in such case Net Sales shall include only subsequent sales by the relevant sublicensee to a third party.  Subject to the foregoing sentence, if any Products are sold or disposed of by Client or its permitted sublicensees other than in a bona fide arm’s length sale exclusively for money, then Net Sales for such products shall be deemed to be [* * *].

 

The amount of any reduction or reversal of any accrual or reserve related to any deduction from the amount invoiced for Products shall be included in Net Sales in the Quarter in which such reduction or reversal occurs.  All calculations shall be made in accordance with GAAP.

 

1.36                        “Parties” and “Party” have the meaning set forth in the introductory paragraph.

 

1.37                        “Pricing Approval” means subsequent to Regulatory Approval, pricing and any relevant reimbursement approval to allow marketing and sales of Products in the given country within the Territory for which such Regulatory Approval relates.

 

1.38                        “Process Inventions” has the meaning set forth in Section 6.1.

 

1.39                        “Product” means each product developed hereunder which uses, contains, comprises or otherwise incorporates a Zydis Formulation.

 

1.40                        “Quarter” means each respective period of three (3) consecutive months ending on March 31st, June 30th, September 30th and December 31st.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.41                        “Recipient” has the meaning set forth in Section 5.1.

 

1.42                        “Records” has the meaning set forth in Section 4.5.

 

1.43                        “Regulatory Approval” means any approvals, permits, product and/or establishment licenses, registrations or authorizations, including approvals pursuant to U.S. Investigational New Drug applications, New Drug Applications and Abbreviated New Drug Applications (or equivalent non-U.S. filings, such as European marketing authorization applications), as applicable of any Regulatory Authorities that are necessary or advisable in connection with the development, manufacture, testing, use, storage, exportation, importation, transport, promotion, marketing, distribution or sale of Products in the Territory, excluding Pricing Approvals.

 

1.44                        “Regulatory Authorities” means the international, federal, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities in the Territory that are responsible for (A) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use or (B) health, safety or environmental matters generally.  In the United States, this includes the FDA; and in the European Union, this includes the EMA.

 

1.45                        “Representatives” of an entity means any of such entity’s duly-authorized officers, directors, employees, agents, accountants, attorneys or other professional advisors.

 

1.46                        “Review Period” has the meaning set forth in Section 4.5.

 

1.47                        “Supplies” has the meaning set forth in Section 2.4(B).

 

1.48                        “Supply Agreement” has the meaning set forth in Section 2.6.

 

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

 

1.50                        “Territory” means worldwide, but excluding any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States.  Catalent shall not be obliged to develop or manufacture Products for sale in any of such countries if it is prevented from doing so, or would be required to obtain or apply for special permission to do so, due to any restrictions (such as embargoes) imposed on it by any governmental authorities, including without limitation, those imposed by the U.S. Office of Foreign Assets Control.

 

1.51                        “Valid Claim” means a claim within the Zydis Patents that is issued or has not been pending more than [* * *] years from the priority date and has not been held invalid by a court of competent jurisdiction after all avenues for appeal have been taken or the time period for the same has expired, or disclaimed or admitted to be invalid or unenforceable through reissue or otherwise, or held unpatentable in a re-examination, opposition or similar proceeding from a patent office of competent jurisdiction after all avenues for appeal have been taken or the time period for the same has expired.

 

1.52                        “Zydis” has the meaning set forth in Recital B.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.53                        “Zydis Formulations” means the formulations of Drug developed hereunder whose development, formulation, manufacture, or sale utilizes or incorporates the Zydis Technology for use in the Field.

 

1.54                        “Zydis Patents” mean the patents and patent applications (until such time as such applications or any of them are denied, abandoned or issued into patents), and patent disclosures, together with all revisions, renewals, extensions, reexaminations, provisionals, reissuances, continuations, continuations-in-part, divisionals, foreign cognates, patents of addition, confirmation patents, registration patents, pipeline protections or supplementary protection certificate related thereto, that include claims relating to fast dissolving drug delivery systems, that Catalent or its Affiliates own or under which Catalent or its Affiliates have in- licensed with the right to sublicense and that would be infringed or misappropriated by the development, manufacture, sale or use of any Product in the Territory.

 

1.55                        “Zydis Technology” has the meaning set forth in Recital B.

 

ARTICLE 2
 DEVELOPMENT PROGRAM

 

2.1                               Development Program.  The Parties have agreed upon, and set forth in Attachment A, requirements and objectives for a program to develop and produce for clinical trials Products suitable for Regulatory Approval and commercialization (as the same may be amended in accordance with the terms of this Agreement, the “Development Program”).

 

2.2                               Performance Standards.  Each Party shall use its commercially reasonable efforts to carry out the responsibilities assigned to it in the Development Program, if any, in a timely manner.  In addition, Client shall use its commercially reasonable efforts to cooperate with Catalent’s conduct of the Development Program, including by timely providing any approvals that may be required during each phase of the Development Program.  Catalent shall keep Client reasonably informed of the progress and all significant developments of the Development Program by delivery of written reports as specified in Attachment A and by participation in telephone conferences from time to time as reasonably requested by Client.

 

2.3                               Amendments to Development Program.  Any material change in the details of the Development Program or the assumptions upon which the Development Program is based may require changes in the pricing and/or time lines, and shall require a written amendment to the Development Program, sometimes referred to as a Quotation Amendment Request or a QAR (a “Change Order”).  Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, pricing, time line or other matter.  The Change Order will become effective upon the execution of the Change Order by both Parties, and following such execution shall be appended hereto as part of Attachment A. Catalent will be given a reasonable period of time within which to implement the changes in an executed Change Order.  Both Parties agree to act in good faith and promptly when considering a Change Order requested by the other Party.  Without limiting the foregoing, Client agrees that it will not unreasonably withhold approval of a Change Order if the proposed changes in pricing or time lines result from, among other appropriate reasons, forces outside the reasonable control of Catalent or changes in the assumptions upon which the initial pricing or time lines were 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

based.  Catalent shall not be obligated to perform any modified or additional changes in the Development Program’s scope until such time as the Parties execute the corresponding Change Order.

 

2.4                               Materials and Supplies.

 

A.                                    Client shall arrange for the delivery, at its own cost and risk, of Drug and any other Client-supplied Materials to the Facility in sufficient quantities and sufficiently in advance of the commencement of the Development Program to permit Catalent to timely perform its obligations hereunder.  Client shall retain title to Client-supplied Materials at all times and shall bear the risk of loss thereof.  Catalent shall take all reasonable steps to store and properly preserve Drug and any other Client-supplied Materials in Catalent’s Facility.  Client shall be responsible at its expense for securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of the Drug and any other Client-supplied Materials.  Prior to delivery of any such items, Client shall provide to Catalent a copy of all associated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws relating to the Drug and any other Client-supplied Materials, and shall promptly provide any updates thereto.  Following receipt of Client-supplied Materials, Catalent shall inspect such items to verify their identity.  Unless otherwise expressly required by the Development Program, Catalent shall have no obligation to test such items to confirm that they meet the associated specifications or certificate of analysis or otherwise; but in the event that Catalent detects a nonconformity with applicable specifications, Catalent shall give Client prompt notice of such nonconformity.

 

B.                                    Shipment of all samples and clinical supplies of Products and Zydis Formulations to be provided to Client pursuant to the Development Program (collectively, the “Supplies”) shall be Ex Works (Incoterms 2010) the Facility.  Catalent shall assist Client and cooperate with Client’s designated common carrier in coordinating such shipments.  Title to the Supplies shall pass to Client when released by Catalent at the Facility to Client’s designated common carrier.

 

2.5                               Clinical and Regulatory.

 

A.                                    Within [* * *] months after the execution of this Agreement, but in any event prior to the delivery by Catalent of any Supplies required to be manufactured in accordance with cGMP, including Supplies to be used in human clinical trials, the Parties shall negotiate in good faith and enter into a Quality Agreement substantially in the form attached hereto as Attachment B. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern.  In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.

 

B.                                    Except as provided for in the following Section 2.5(C), Catalent shall obtain and maintain all necessary Regulatory Approvals with respect to general Facility operations 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

7

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

or that may be required for Catalent to conduct the Development Program, including manufacturing of the Supplies, and to comply with all Applicable Laws in this respect.

 

C.                                    Client shall be responsible for conducting the clinical program (i.e., all activities relating to the planning and execution of pre-clinical and clinical studies in animals or humans directed towards obtaining Regulatory Approval for marketing) with respect to Products and for preparing and filing regulatory submissions in the Territory with respect thereto, including any expenses associated therewith pursuant to Section 4.4.  Client shall obtain and maintain all necessary Regulatory Approvals and Pricing Approvals that may be required for Client to conduct the clinical program with respect to Products and commercialize Products in the Territory and to comply with all Applicable Laws in this respect, including filing all periodic reports, safety reports, and all other notifications as required by the Regulatory Authorities.  Client shall be responsible for retaining and maintaining all study records, financial information, and reserve samples, as required under Applicable Law, generated or used in the execution of the pre-clinical and clinical studies in animals or humans performed in accordance with this Agreement.

 

D.                                    Catalent will co-operate with Client, upon Client’s reasonable request and at Client’s cost, to assist Client in obtaining and maintaining Regulatory Approvals that may be required for Client to fulfill its obligations under Section 2.5(C); provided, however, Client shall not identify Catalent in any regulatory filing or submission without Catalent’s prior written consent unless required by Applicable Law, including disclosure of Catalent as the manufacturer of the Product.  Such consent shall not be unreasonably withheld or delayed and shall be memorialized in a writing signed by authorized representatives of both Parties.

 

E.                                     Client shall use its commercially reasonable efforts to carry out its responsibilities under this Section 2.5 with the objective of satisfying the requirements of Regulatory Authorities as effectively and expeditiously as possible and to enhance the prospects of the overall commercial success of the Products.

 

F.                                      Each Party shall (i) promptly notify the other Party promptly of any Regulatory Authority inspection, inquiry or correspondence concerning the Products, including inspections of investigational sites or laboratories and (ii) to the extent permitted by Applicable Laws promptly forward to the other Party copies of any correspondence from or to any Regulatory Authority relating to any such inspection, inquiry or correspondence or otherwise relating to Products, including FDA Form 483 notices, and FDA refusal to file, deficiency, rejection or warning letters (or equivalent non-U.S. documents), purged only of Confidential Information that is unrelated to the Products.

 

2.6                               Commercial Supply.  After the receipt of the final report required pursuant to the Development Program, Client shall notify Catalent within [* * *] thereafter whether or not it desires to proceed with commercialization of any Products; provided that such time period may be extended by Catalent upon the reasonable request of Client for up to an additional [* * *].  If Client desires to proceed with commercialization, then Client and Catalent (or one of its Affiliates) shall enter into good faith negotiations for a separate supply agreement [* * *] (any such agreement, a “Supply Agreement”).

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

8

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

2.7                               Exclusivity.  Catalent agrees that, for the period commencing on the Effective Date and ending when Client notifies Catalent, in accordance with Section 2.6, whether or not it desires to proceed with commercialization of any Products, Catalent will not enter into any agreement, arrangement, understanding or negotiations with any third party relating to the application of the Zydis Technology to formulations of Drug in the Territory.  If Client notifies Catalent that it does desire to proceed with such commercialization, the period described in the preceding sentence will be extended for an additional thirty (30) days (or until a Supply Agreement is executed, if earlier).

 

2.8                               Non-Compete.  Catalent agrees that during the Term of this Agreement and for a period of [* * *] after the end of such Term (the “Non-Compete Period”), Catalent shall not, without the prior written consent of Client, directly or indirectly develop or manufacture for itself or for any other person or entity, other than Client, a formulation of the Drug that uses or employs the Zydis Technology in the Field.  This non-compete covenant shall terminate upon any earlier termination of this Agreement pursuant to Sections 11.2, 11.3 or 11.4 hereof and may only be extended by mutual written agreement of the Parties.  During the Term or Non-Compete Period, if Client no longer wishes to pursue a formulation of the Drug that uses or employs the Zydis Technology in the Field, then Client shall promptly provide Catalent with written notification of its decision, and the non-compete covenant described herein shall terminate as of the date of such notice.

 

ARTICLE 3
 LICENSE

 

3.1                               Grant.  Subject to the terms of this Agreement, including the payment of the license fees and royalties described in Sections 4.1(D) and (E), Catalent hereby grants to Client an exclusive license, with the right to sublicense subject to Section 3.2, under the Zydis Technology for the sole purposes of using and selling (but not manufacturing except as provided in Attachment C and the Supply Agreement) Products in the Field in the Territory.  Notwithstanding the foregoing, Catalent shall retain such rights under the Zydis Technology as may be required to allow Catalent to carry out its obligations under the Development Program and any Supply Agreement.  Any rights under the Zydis Technology not expressly granted to Client in this Section 3.1 shall be retained by Catalent.

 

3.2                               Sublicenses.  Client may sublicense to any of its Affiliates any of the rights granted to Client pursuant to Section 3.1 (without the right to further sublicense), or to third parties any of the rights granted to Client pursuant to Section 3.1 (without the right to further sublicense) upon the prior written consent of Catalent, which shall not be unreasonably withheld; provided, that Client shall provide to Catalent within five (5) days after execution a copy of each sublicense agreement with any sublicensee that is not an Affiliate.  Client shall ensure that each sublicensee accepts in writing and complies with all of the terms and conditions of this Agreement as if such sublicensee were a Party to this Agreement, and Client shall guarantee and be responsible for its sublicensees’ performance under (and breach of) this Agreement.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

9

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

3.3          Trademark.  In the event Client desires to use the trademark ZYDIS® in connection with the use or sale of the Products permitted hereunder, the Parties shall negotiate in good faith a royalty-free trademark license agreement on Catalent’s standard terms.

 

3.4          Client Technology.  Client hereby grants to Catalent a non-exclusive, fully paid-up and royalty-free license, with the right to sublicense to Catalent’s Affiliates, under any and all technology owned by or licensed to Client with respect to the Drug or any formulations of the Drug for the sole purpose of carrying out Catalent’s obligations under this Agreement, the Development Program and any Supply Agreement.

 

ARTICLE 4
 PAYMENTS

 

4.1          Fees.  In consideration for Catalent conducting the Development Program and granting to Client the rights pursuant to Section 3.1:

 

A.            Performance Fees. Client shall pay to Catalent the milestone or other performance-based fees described in the Development Program.  Such fees shall be paid within [* * *] days following invoice, which invoice shall be submitted to Client by Catalent upon the occurrence of each such milestone event, and shall be non-refundable and non-creditable.

 

B.            Fees for Supplies.  Client shall pay to Catalent the fees relating to the manufacture and delivery of Supplies as described in the Development Program, if any, and as described in Section 2.4.  Such fees shall be paid within [* * *] days following invoice, which invoice shall be submitted to Client by Catalent upon tender of delivery of the relevant Supplies to the designated carrier.

 

C.            Retesting.  All retesting performed that is not due to a Catalent error will be billed to Client.  All required investigational studies or additional Client requests not outlined in the Development Program will be invoiced for the cost of performance at the current standard pricing.

 

D.            Milestones.

 

(i)            On the Effective Date, Client shall pay to Catalent $275,000.00.

 

(ii)           For each Product developed hereunder, Client shall pay to Catalent the following non-refundable and non-creditable milestone payments in connection with Client’s license of the Zydis Technology:

 

i.              $[* * *] invoiced after [* * *]; and

 

ii.             $[* * *] invoiced after [* * *].

 

Client shall notify Catalent of the achievement of each such milestone within [* * *] business days following achievement.  Such milestones shall be paid within [* * *] 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

10

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

days following invoice, which invoice shall be submitted to Client by Catalent promptly following receipt of Client’s notification.

 

E.            Royalties.  Client shall pay to Catalent, on a calendar quarter basis, a royalty in connection with Client’s license of the Zydis Technology equal to [* * *]% of Net Sales.  The foregoing royalty shall decrease by [* * *]% to [* * *]% of Net Sales effective as of the first Quarter following the expiration or other lapse of the last Valid Claim covering any Zydis Formulation; provided, however, in the event that a patent is issued that protects any Zydis Formulation or an extension of an existing patent covering any Zydis Formulation be granted, such royalty rate shall be increased back to [* * *]% of Net Sales for the life of such patent’s Valid Claim(s).  Client shall deliver to Catalent within [* * *] days following the end of each Quarter following the First Launch Date: (i) a written statement setting forth in reasonable detail its calculation of the royalty due for such most recently completed Quarter, including its calculation of Net Sales and all appropriate backup information, and (ii) payment of the royalty due on such Net Sales.

 

F.             Other Fees.  Client shall pay Catalent for all other fees and expenses of Catalent owing in accordance with the terms of this Agreement, including, if and when applicable, any cancellation fees set forth in the Development Program and any payments Catalent is required to make to any Regulatory Authority pursuant to Applicable Laws resulting from Catalent’s formulation, development, manufacturing, processing, filling, packaging or testing of Product at the Facility (including without limitation any payments or fees Catalent is required to make pursuant to the Generic Drug User Fee Act of 2012, if applicable).  Such fees and expenses shall be paid within [* * *] days following invoice, which invoice shall be submitted to Client by Catalent as and when appropriate.

 

4.2          Payment Terms.  Client shall make payment as directed in the applicable invoice.  In the event payment (except for any amount disputed that will be subject to Section 13.10) is not received by Catalent on or before the [* * *] day after the date of the invoice, then Catalent may, in addition to any other remedies available at equity or in law, at its option, elect to do any one or more of the following: (A) charge interest on the outstanding sum from the due date (both before and after any judgment) at [* * *]% per month until paid in full (or, if less, the maximum amount permitted by Applicable Laws); (B) suspend any further performance hereunder until such invoice is paid in full; and/or (C) terminate this Agreement pursuant to Section 3.  Except as expressly set forth in the Development Program, all payments hereunder shall be made in U.S. dollars.  If Net Sales are invoiced by Client or its Affiliates or any permitted sublicensees to third parties in other currencies, royalties due on such Net Sales pursuant to Section 4.1(E) shall be converted into U.S. dollars in accordance with GAAP at the closing rates of exchange as published in The Wall Street Journal, in effect on the last business day of the month within the calendar quarter for which royalties are due.

 

4.3          Taxes.  All taxes, duties and other amounts assessed (excluding tax based on net income and franchise taxes) on services, components, Drug or Supplies prior to or upon provision or sale to Catalent or Client, as the case may be, and on any other Client-supplied Materials, are the responsibility of Client, and Client shall reimburse Catalent for all such taxes, duties or other expenses paid by Catalent or such sums will be added to invoices directed at Client, where applicable.  If any deduction or withholding in respect of tax or 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

11

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

otherwise is required by law to be made from any of the sums payable as mentioned in Section 4.1, Client shall be obliged to pay to Catalent such greater sum as will leave Catalent, after deduction or withholding as is required to be made, with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding.

 

4.4          Client and Third Party Expenses.  Except as may be expressly set forth in the Development Program, Client shall be responsible for 100% of its own and all third-party expenses associated with the development, Regulatory Approval and commercialization of Products, including regulatory filings, pre-clinical studies and clinical studies.

 

4.5          Records; Audit Rights.  Client will keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”).  Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records.  Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question.  Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate.  Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request.  Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement.  Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”).  Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies.  If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report.  Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.

 

4.6          Development Batches.  Each batch of Supplies produced under this Agreement will be considered to be a “Development Batch” until manufacturing, testing and storage methods and processes have been validated or qualified in accordance with industry standards (including production of at least [* * *] consecutive batches of Supplies that meet the 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

12

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

applicable specifications).  The term “Development Batch” shall include any batch manufactured following (A) a Change Order, or (B) a scale-up in the manufacturing process to produce greater quantities of Supplies, until Catalent has manufactured at least [* * *] consecutive batches of Supplies meeting the new specifications.  Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch.  Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-specification batch.

 

ARTICLE 5
 CONFIDENTIALITY AND NON-USE

 

5.1          Definition.  As used in this Agreement, the term “Confidential Information” includes all information furnished by or on behalf of Catalent or Client (the “Discloser”), its Affiliates or any of its or their respective Representatives, to the other Party (the “Recipient”), its Affiliates or any of its or their respective Representatives, whether furnished before, on or after the Effective Date and furnished in any form, including written, verbal, visual, electronic or in any other media or manner and information acquired by observation or otherwise during any site visit at the other Party’s facility.  Confidential Information includes all proprietary technologies, inventions and any other Intellectual Property, analyses, compilations, business or technical information and other materials prepared by either Party, their respective Affiliates, or any of its or their respective Representatives, containing or based in whole or in part on any information furnished by the Discloser, its Affiliates or any of its or their respective Representatives.  Confidential Information also includes the existence of this Agreement and its terms (including all Attachments).

 

5.2          Exclusions.  Notwithstanding Section 5.1, Confidential Information does not include information that (A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, (B) is already known by the Recipient at the time of disclosure as evidenced by the Recipient’s written records, (C) becomes available to the Recipient on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis or (D) was or is independently developed by or for the Recipient without reference to the Confidential Information of the Discloser as evidenced by the Recipient’s written records.

 

5.3          Mutual Obligation.  The Recipient agrees that it will not use the Discloser’s Confidential Information except in connection with the performance of its obligations hereunder (except that Confidential Information necessary for manufacture or production of a Product may be used during any commercialization pursuant to a Supply Agreement).  Recipient will not disclose, without the prior written consent of the Discloser, Confidential Information of the Discloser to any third party, except that the Recipient may disclose the Discloser’s Confidential Information to any of its Affiliates and its or their respective Representatives that (A) need to know such Confidential Information for the purpose of performing under this Agreement, (B) are advised of the contents of this Article 5 and (C) are bound to the Recipient by obligations of confidentiality at least as restrictive as the terms of this Article 5.  Each Party shall be responsible for any breach of this Article 5 by its Affiliates or any of its or their respective Representatives.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

13

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

5.4          Permitted Disclosure.  The Recipient may disclose the Discloser’s Confidential Information to the extent required by Applicable Law, regulation or court or administrative order; provided, that prior to making any such legally required disclosure, the Recipient shall give the Discloser as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances.  Any such disclosure, however, shall not relieve the Recipient of its obligations contained herein.

 

5.5          No Implied License.  Except as expressly set forth in this Article 5, the Recipient will obtain no right of any kind or license under any Confidential Information of the Discloser, including any patent application or patent, by reason of this Agreement.  Subject to Article 6, all Confidential Information will remain the sole property of the Discloser.

 

5.6          Return of Confidential Information.  Upon expiration or termination of this Agreement, the Recipient will (and will cause its Affiliates and its and their respective Representatives to) cease its and their use and, upon written request, within thirty (30) days either return or destroy (and certify as to such destruction) all Confidential Information of the Discloser, including any copies thereof, except for a single copy which may be retained for the sole purpose of ensuring compliance with its obligations under this Agreement; provided that such retained copy shall remain subject to the obligations of confidentiality set forth herein.

 

5.7          Survival.  The obligations of this Article 5 will terminate five (5) years from the expiration or termination of this Agreement.

 

ARTICLE 6
 INTELLECTUAL PROPERTY

 

6.1          Definitions.  For purposes hereof, “Intellectual Property” means all intellectual property (whether or not patented), including without limitation, patents, patent applications, know-how, trade secrets, copyrights, trademarks, designs, concepts, technical information, manuals, standard operating procedures, instructions, specifications, inventions, discoveries, processes, data, improvements and developments.  “Client IP” means (i) all Intellectual Property and embodiments thereof owned by or licensed (other than by Catalent) to Client as of the date hereof or developed (other than by Catalent) by or for Client other than in connection with this Agreement, including Client’s proprietary formulation of the Drug, and (ii) all Inventions (as defined in the Evaluation Agreement) described in subclauses (A) and (B) in the third sentence of clause K of Attachment A to the Evaluation Agreement developed at any time during the term of the Evaluation Agreement.  “Catalent IP” means all Intellectual Property and embodiments thereof owned by or licensed to Catalent as of the date hereof or developed by Catalent other than in connection with this Agreement; “Invention” means any Intellectual Property developed by either Party or jointly by the Parties in connection with this Agreement (including all Change Orders under this Agreement); [* * *].

 

6.2          Disclosure of Inventions.  Client shall promptly provide written notice to Catalent of Inventions developed by Client.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

14

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

6.3          Ownership of Intellectual Property.  All Client IP and Client Inventions shall be owned solely by Client and no right therein is granted to Catalent under this Agreement, except that Catalent shall have a non-exclusive, fully paid-up, royalty-free license pursuant to Section 3.4 to such Client IP and Client Inventions and, as applicable, the Client-supplied Materials, solely to the extent necessary to perform its obligations under this Agreement, the Development Program and any Supply Agreement.  All Catalent IP and Process Inventions shall be owned solely by Catalent and except as set forth in Section 3.1 no other right therein is granted to Client under this Agreement.

 

6.4          Patentable Inventions.  In the event that any Inventions may be patentable:

 

A.            the Party owning such Invention pursuant to Section 6.3 shall have the right, in its sole discretion, to determine the patent strategy for such Invention, which may include not obtaining patent protection in a particular country or any country;

 

B.            without prejudice to the generality of Section 6.4, the Party not owning an Invention shall cooperate with the other Party and/or its attorneys upon reasonable request, at the expense of the other Party, in (i) properly filing and prosecuting patent applications, (ii) vesting title herein provided and (iii) providing non-financial assistance in enforcing any patents resulting from such patent applications; and

 

C.            the cost of patenting Inventions will be borne by the owner of the Invention.

 

6.5          Assignment of Rights.  Each of Client and Catalent shall, and does hereby, assign, and shall cause its Affiliates, employees, consultants and agents to so assign with full title guarantee, to the other Party, without additional compensation, such right, title and interest in and to any Intellectual Property (including Inventions) as is necessary to fully effect the ownership provisions set out in this Article 6 and any accrued rights of action in respect thereof.  Each of Client and Catalent shall, if so requested by the other Party, execute all such documents and do all such other acts and things as may be reasonably required to comply with this Article 6 to vest in the appropriate Party all rights in the relevant Intellectual Property and shall procure execution by any named inventor of all such documents as may reasonably be required by the other Party in connection with any related patent application.

 

6.6          [* * *].

 

6.7          Enforcement of Zydis Patents.  If either Party becomes aware of any third party infringement or threatened infringement of any of the Zydis Patents, the following shall apply:

 

A.            The Party becoming so aware shall promptly give written notice to the other Party of such infringement or threatened infringement describing the facts relating thereto in reasonable detail, including a copy of any written correspondence received from third parties.

 

B.            If there is disagreement between the Parties as to whether the third party act is in fact an infringement of any of the Zydis Patents or whether an infringement Action would stand a reasonable chance of success, the Parties shall refer such issue to an independent experienced intellectual property counsel, and the costs incurred in this regard shall be borne 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

15

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

by the Party whose view does not prevail.  Each Party shall have the right to present evidence in support of its position to the independent intellectual property counsel.

 

C.            With or without the advice of independent intellectual property counsel pursuant to clause (B), Catalent shall have the initial right, but not the obligation, to pursue any alleged third party infringement of any of the Zydis Patents in any country, within or outside the Territory.  Catalent shall notify Client within ninety (90) days after delivery of any notice pursuant to clause (A) (or, if later, thirty (30) days after the decision of the intellectual property counsel described in clause (B)) whether it intends to so pursue.  Catalent may agree to settle any such Action in its sole discretion; provided that Catalent will not settle any such Action if such settlement would adversely affect the rights or interests of Client without the prior written consent of Client, which shall not be unreasonably withheld, conditioned or delayed.  If Catalent elects to pursue such third party infringement, then Catalent shall bear the cost of such Action and Catalent shall be entitled to retain all sums recovered in such Action for its own account.

 

D.            If Catalent elects not to pursue any Action in accordance with clause (C) and the intellectual property counsel described in clause (B) has opined that the third party act is, or most likely is, an infringement of a Zydis Patent in the relevant country of the Territory, then Client may, in its sole discretion and expense, bring suit in its name to restrain such third party infringement in such country of the Territory.  To the extent that Catalent must be named as a necessary party to the litigation, Catalent agrees to be so named.  In such event, Client shall conduct such Action properly and diligently and shall keep Catalent reasonably informed, including by providing copies of all litigation filings and material correspondence.  Client will not settle any such Action without the prior written consent of Catalent.  If Client elects to pursue such third party infringement Action, then Client shall bear the cost of such Action.  Any proceeds recovered by Client from such Action shall be used to reimburse Client and Catalent for their costs and expenses reasonably incurred in connection with such Action (including attorneys’ and experts’ fees), if any, and then any remaining proceeds shall be retained by Client and treated as Net Sales accruing during the Quarter in which such proceeds are actually remitted to Client.

 

6.8          Defense of Zydis Formulations.  If either Party becomes aware of any third party Action alleging infringement or threatened infringement of any third party Intellectual Property rights by the development, use, sale or manufacture of any Zydis Formulation, the following shall apply:

 

A.            The Party becoming so aware shall promptly give written notice to the other Party of such Action describing the facts relating thereto in reasonable detail, including a copy of any written correspondence received from third parties, and shall keep the other Party informed of all developments related to such alleged infringement.  Without limiting the generality of the foregoing, Client shall promptly inform Catalent in writing if Client becomes aware that a third party has initiated or filed any Action alleging that the Zydis Technology embodied in any Zydis Formulation infringes the Intellectual Property rights of such third party.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

16

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

B.            Catalent shall have the initial right, but not the obligation, to prosecute and control the defense of any such third party Action using counsel of its choice.  Catalent may agree to settle any such Action in its sole discretion; provided that Catalent will not settle any such Action with a third party plaintiff if such settlement would adversely affect the rights or interests of Client without the prior written consent of Client, which shall not be unreasonably withheld, conditioned or delayed.  If Catalent assumes the defense of such Action, then Catalent shall bear the cost of such defense, and Catalent shall be entitled to retain all sums recovered in such Action for its own account.

 

C.            If Catalent elects not to defend such Action in accordance with clause (B) within 75 days after delivery of any notice pursuant to clause (A), or not less than 7 days before a response is due as is required to respond to a complaint if a complaint has been filed, then Client may assume the defense of such Action using counsel of its choice solely to the extent that such Action involves the Zydis Technology embodied in any Zydis Formulation.  Client shall not settle any Action without (i) a full release of both Parties and their respective Affiliates from such third party plaintiff and (ii) the prior written consent of Catalent, which shall not be unreasonably withheld, delayed or conditioned.  If Client assumes the defense of such Action, then Client shall bear the cost of such defense.  Any proceeds recovered by Client from such Action shall be used to reimburse Client and Catalent (to the extent either Party incurs any costs or expenses in relation to such Action) for their costs and expenses reasonably incurred in connection with such Action (including attorneys’ and experts’ fees) and then any remaining proceeds shall be retained by Client and treated as Net Sales accruing during the Quarter in which such proceeds are actually remitted to Client.

 

D.            Notwithstanding the foregoing, where any Action alleges that (i) Catalent IP and/or Process Inventions and (ii) Client IP and/or Client Inventions, infringe the Intellectual Property rights of a third party, then irrespective of which Party controls the defense of such Action, the Parties will discuss in good faith how to defend such Action.

 

6.9          Cooperation.  In any Action pursuant to Sections 6.7 or 6.8, the Parties shall provide each other with reasonable cooperation and assistance and, upon the request and at the expense of the Party making such request, the other Party shall make available, at reasonable times and under appropriate conditions, all relevant records and personnel currently employed by such Party.

 

6.10        No Challenge.  As long as Client has any license rights pursuant to this Agreement, Client shall not dispute or challenge in any manner Catalent’s ownership of, rights to or the validity or enforceability of any of the Zydis Technology licensed to Client pursuant to this Agreement.

 

ARTICLE 7
 REPRESENTATIONS AND WARRANTIES

 

7.1          Catalent.  Catalent represents, warrants and undertakes to Client that:

 

A.            this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client,

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

17

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity;

 

B.            Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement;

 

C.            at the time of delivery by Catalent to the designated carrier hereunder, the Supplies shall have been manufactured in accordance with Applicable Laws and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging and labeling) provided to Catalent by Client or its Affiliates;

 

D.            (i) to Catalent’s knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement;

 

E.            no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and

 

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

 

7.2          Client.  Client represents, warrants and undertakes to Catalent that:

 

A.            this Agreement has been duly executed and delivered by Client’s authorized representative and, assuming the due authorization, execution and delivery hereof by Catalent, constitutes and will at all times constitute the legal, valid and binding obligation of Client enforceable against Client in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity;

 

B.            Client has no obligations, contractual or otherwise, that would conflict with Client entering into and performing its obligations set forth in this Agreement;

 

C.            at the time of delivery hereunder, to Client’s knowledge, all Drug and other Client-supplied Materials supplied by it or its Affiliates hereunder shall have been 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

18

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

manufactured in accordance with Applicable Laws, shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws and shall meet the applicable specifications and will continue to do so until the applicable expiration date;

 

D.            Client has provided to Catalent all safe handling instructions, health and environmental information and material safety data sheets applicable to the Drug and other Client-supplied Materials supplied by it or its Affiliates hereunder in sufficient time for review and training by Catalent;

 

E.            (i) to Client’s knowledge and except pursuant to which Client has a valid license, it has all necessary authority to use and to permit Catalent to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Client IP related to the Drug and all other Client-supplied Materials, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Client’s knowledge and except pursuant to which Client has a valid license, there are no patents owned by others that would be infringed or misused by Client’s performance of the Agreement; and (iii) to Client’s knowledge and except pursuant to which Client has a valid license, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Drug or other Client-supplied Materials that would be infringed or misused by Client’s performance of this Agreement;

 

F.             all Products, Supplies, results, data, samples and other materials and deliverables provided to Client by Catalent hereunder shall be held, used and disposed of by or on behalf of Client as set forth in the Development Program and otherwise in accordance with all Applicable Laws (including, in connection with any Supplies or other Products that are not labeled, 21 CFR § 201.150 and equivalent non-U.S. regulations); specifically, Client shall not permit the human consumption of any Supplies or other Products, except to the extent such consumption occurs in the course of clinical studies that expressly permit such use and that have been approved by appropriate governmental authorities; and Client will otherwise comply with all Applicable Laws applicable to Client’s performance under this Agreement;

 

G.            to Client’s knowledge, the services to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, trade name, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity; and

 

H.            no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America.

 

7.3          Limitations.  THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 7 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER PARTY, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

19

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

ARTICLE 8
 INDEMNIFICATION

 

8.1          Indemnification by Catalent.  Catalent shall indemnify and hold harmless Client, its Affiliates, and their respective directors, officers, employees and agents (“Client Indemnitees”) from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees and reasonable investigative costs) in connection with any suit, demand or action by any third party (“Losses”) arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement or (B) any gross negligence or willful misconduct by Catalent; except to the extent that any of the foregoing arises out of or results from any Client Indemnitee’s negligence, willful misconduct or breach of this Agreement.

 

8.2          Indemnification by Client.  Client shall indemnify and hold harmless Catalent, its Affiliates, and their respective directors, officers, employees and agents (“Catalent Indemnitees”) from and against any and all Losses arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement, (B) any development, manufacture, packaging, sale, promotion, distribution, importation, exportation, storage, handling, transportation, disposition or use of or exposure to the Drug, Supplies or any other Zydis Formulation, including product liability or strict liability, (C) Client’s exercise of control over the Development Program to the extent that Client’s instructions or directions violate Applicable Laws, (D) the conduct of any clinical trials utilizing the Drug, Supplies or any other Zydis Formulation, (E) any actual or alleged infringement or violation of any third party patent, trade secret, copyright, trademark or other proprietary rights arising from or by intellectual property or information provided by Client, including Client-supplied Materials, or (F) any gross negligence or willful misconduct by Client; except to the extent that any of the foregoing arises out of or results from any Catalent Indemnitee’s negligence, willful misconduct or breach of this Agreement.

 

8.3          Indemnification Procedures.  All indemnification obligations in this Agreement are conditioned upon the Party seeking indemnification (A) promptly notifying the indemnifying Party of any claim or liability of which the Party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying Party of any of its obligations hereunder except to the extent the indemnifying Party is prejudiced by such failure, (B) allowing the indemnifying Party, if the indemnifying Party so requests, to conduct and control the defense of any such claim or liability and any related settlement negotiations (at the indemnifying Party’s expense), (C) cooperating with the indemnifying Party in the defense of any such claim or liability and any related settlement negotiations (at the indemnifying Party’s expense) and (D) not compromising or settling any claim or liability without prior written consent of the indemnifying Party.  Without limiting the generality of the foregoing, the indemnifying Party is authorized to direct all aspects of the defense for which it has an obligation of indemnification and defense hereunder, including without limitation, selection of counsel, discovery, motions and settlement;

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

20

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

provided, however, the indemnifying Party may not settle or dispose of any such matter (i) without obtaining a full release in favor of the indemnified Party with respect to such matter and (ii) if such settlement or disposition would confess wrongdoing or otherwise adversely impact the rights or interests of the indemnified Party, in each case, without the prior written consent of the indemnified Party.

ARTICLE 9
 LIMITATIONS OF LIABILITY

 

9.1          CATALENT SHALL HAVE NO LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED DRUG OR OTHER CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT SUCH DRUG OR CLIENT-SUPPLIED MATERIALS ARE INCORPORATED INTO ZYDIS FORMULATIONS, EXCEPT ARISING FROM CATALENT’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

 

9.2          CATALENT’S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS AGREEMENT BY CLIENT TO CATALENT FOR THE DEVELOPMENT PROGRAM. Nothing in this Section 9.2 or in any other provision of this Agreement shall, to the extent applicable, limit the liability of Catalent for (A) death or personal injury arising from Catalent’s or any of its Affiliate’s negligence, (B) for the fraud of Catalent, any of its Affiliates or any their respective Representatives, (C) any breach of Catalent’s obligations under s12 of the Sale of Goods Act 1979 or s2 of the Supply of Goods and Services Act 1982 or (D) any matter for which it would be illegal for Catalent or any of its Affiliates to exclude or to attempt to exclude liability.

 

9.3          NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES, PROFITS OR DATA ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

ARTICLE 10
 INSURANCE

 

Each Party shall, at its own cost and expense, obtain and maintain in full force and effect during the Term the following: (A) Commercial General Liability Insurance with a per-occurrence limit of an amount equivalent to $[* * *]; (B) Products and Completed Operations Liability Insurance (including coverage for Products used in clinical trials) with a per-occurrence limit of an amount equivalent to (i) $[* * *] prior to the first administration of Product in a human and (ii) $[* * *] in the aggregate thereafter; (C) Workers’ Compensation Insurance with statutory limits and Employers Liability Insurance with limits of an amount equivalent to $[* * *] per accident; and (D) All Risk Property Insurance, including transit coverage, in an amount equal to the full replacement value of its property while in, or in transit to, a Catalent facility as required under this Agreement.  Each Party may self-insure all or any portion of the required insurance as long as, together with its Affiliates, its US GAAP 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

21

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

net worth is greater than $[* * *] million or its annual EBITDA (earnings before interest, taxes, depreciation and amortization) is greater than $[* * *] million.  Each required insurance policy, other than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A-VII. If any of the required policies of insurance are written on a claims made basis, such policies shall be maintained throughout the Term and for a period of at least [* * *] years thereafter.  Each Party shall obtain a waiver of subrogation clause from its property insurance carriers in favor of the other Party.  Each Party shall be named as an additional insured within the other Party’s products liability insurance policies; provided, that such additional insured status will apply solely to the extent of the insured Party’s indemnity obligations under this Agreement.  Such waivers of subrogation and additional insured status obligations will operate the same whether insurance is carried through third parties or self-insured.  Upon the other Party’s written request from time to time, each Party shall promptly furnish to the other Party a certificate of insurance or other evidence of the required insurance.

 

ARTICLE 11
 TERM AND TERMINATION

 

11.1        Term.  This Agreement shall commence on the Effective Date and shall continue on a country-by-country basis until the later of (A) ten (10) years after Launch of the most recently Launched-Product in such country and (B) the expiration of the last Valid Claim covering each Product in such country unless earlier terminated in accordance with Section 11.3 (as may be extended in accordance with this Section 11.1, the “Term”).  The Term shall automatically be extended for successive one (1) year periods unless and until one Party gives the other Party at least one hundred eighty (180) days prior written notice of its desire to terminate as of the end of the then-current Term.

 

11.2        Termination by Catalent.  Catalent may, at its option in its sole discretion, (x) terminate this Agreement in its entirety or (y) terminate the exclusive nature of this Agreement by adding multiple additional licensees on a country-by-country basis in the Territory with respect to the relevant country, at any time during the Term immediately on written notice to Client if with respect to any country in the Territory:

 

A.            Client directly or indirectly (i) opposes or assists any Party to oppose the grant of a patent on any patent application or any extension of or the grant of a supplementary protection certificate within the Zydis Patents or (ii) disputes or directly or indirectly assists any third party to dispute the validity or enforceability of any patent within the Zydis Patents or any of the claims thereof;

 

B.            Client shall have failed to file an investigational new drug (IND) application (or equivalent) with the FDA or EMA within [* * *] of the Effective Date;

 

C.            Client fails to file a new drug application (NDA) (or equivalent) with the FDA or EMA within [* * *] of the Effective Date;

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

22

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

D.            Client fails to obtain Regulatory Approval to market and sell the Products within [* * *] after the filing of a NDA (or equivalent) with a Regulatory Authority except for circumstances outside Client’s control;

 

E.            Client shall have failed to Launch a Product within [* * *] following receipt of all required Regulatory Approvals and Pricing Approvals; or

 

F.             Client shall have failed to use its commercially reasonable efforts to promote the demand for Products within the Territory.

 

Notwithstanding the foregoing, Client may extend any of the deadlines in clauses A, B, C, D, E and F in this Section 11.2 by a period of [* * *] by providing prior notice to Catalent that a deadline will be missed and by paying Catalent an extension payment of $[* * *] on or before the date of the applicable deadline prior to its extension.  Client shall have the right to exercise this remedy up to [* * *] times during the life of the definitive agreement.

 

11.3        Voluntary Termination by Client.  Client may terminate this Agreement without cause at any time during the Term on 90 days prior written notice to Catalent.  Upon receipt by Catalent of any such termination notice, Catalent will promptly cease or wind down, as appropriate, work under the Development Program unless otherwise requested by Client in such notice.

 

11.4        Mutual Termination Rights.  Either Party may terminate this Agreement immediately without further action if (A) the other Party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver, administrative receiver, trustee or administrator, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days, or takes any equivalent or similar action in consequence of debt in any jurisdiction or (B) the other Party materially breaches any of the provisions of this Agreement and such breach is not cured within [* * *] days after the giving of written notice requiring the breach to be remedied; provided, that in the case of a failure of Client to make payments in accordance with the terms of this Agreement, Catalent may terminate this Agreement if such payment breach is not cured within [* * *] days of receipt of written notice of non-payment from Catalent.

 

11.5        Effect of Termination.  Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either Party prior to such expiration or termination.  In the event this Agreement is terminated, Client shall pay Catalent (A) for all services performed pursuant to the Development Program up to the effective date of termination, (B) for all costs and expenses incurred, and all noncancellable commitments made, by Catalent or its Affiliates in the performance of the Development Program, and (C) any applicable cancellation fees as set forth in the Development Program, is not in connection with a completed phase of the Development Program and was not effected prior to the commencement of the next phase of the Development Program, an amount equal to the value of the services that would have been performed by Catalent in order to complete the then-current phase of the Development Program.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

23

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

11.6        Survival.  The rights and obligations of the Parties shall continue under Articles 5 (Confidentiality and Non-Use), 6 (Intellectual Property), 8 (Indemnification), 9 (Limitations of Liability), 12 (Notice), 13 (Miscellaneous) and 10 (Insurance); and under Sections 2.6 (Commercial Supply), 4.2 (Payment Terms), 4.3 (Taxes), 4.4 (Client and Third Party Expenses), 4.5 (Records; Audit Rights), 7.3 (Limitations on Warranties), 11.5 (Effect of Termination) and 11.6 (Survival), in each case in accordance with their respective terms if applicable, notwithstanding expiration or termination of this Agreement.

 

ARTICLE 12
 NOTICE

 

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally or by hand; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if sent by registered or certified mail (return receipt requested), postage prepaid; (D) when sent by electronic mail or email transmission (receipt verified) or (E) when delivered, if sent by express courier service, in each case, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):

 

	
To Client:
    	
Biohaven Pharmaceutical   Holding Company Ltd.
    
	
 
    	
234 Church Street,   Suite 301
    
	
 
    	
New Haven, CT 06510 USA
    
	
 
    	
Attn: Robert M. Berman,   M.D. Chief Medical Officer
    
	
 
    	
email: [* * *]
    
	
 
    	
 
    
	
With a copy to:
    	
Locke Lord LLP
    
	
 
    	
2800 Financial Plaza
    
	
 
    	
Providence, RI 02903   USA
    
	
 
    	
Attn: Douglas   Gray, Esq.
    
	
 
    	
Facsimile: (888)   325-9018
    
	
 
    	
email: [* * *]
    
	
 
    	
 
    
	
To Catalent:
    	
Catalent U.K. Swindon   U.K. Zydis Ltd.
    
	
 
    	
Frankland Road,   Blagrove
    
	
 
    	
Swindon, Wiltshire, UK   SN5 8YG
    
	
 
    	
Attn: General Manager
    
	
 
    	
Facsimile: 44 1793   548340
    
	
 
    	
 
    
	
With a copy to:
    	
Catalent Pharma   Solutions, LLC
    
	
 
    	
14 Schoolhouse Road
    
	
 
    	
Somerset, New Jersey   08873
    
	
 
    	
USA
    
	
 
    	
Attn: General Counsel   (Legal Department)
    
	
 
    	
Facsimile: +1 (732)   537-6491
    

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

24

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

ARTICLE 13
 MISCELLANEOUS

 

13.1        Entire Agreement; Amendments.  This Agreement, including any Change Orders or other amendments to any of the foregoing constitutes the entire understanding between the Parties, and supersedes any contracts, agreements or understandings (oral or written) of the Parties, with respect to the subject matter hereof, including, for avoidance of doubt, the Evaluation Agreement; provided, however, Attachment B to the Evaluation Agreement shall be of no further force and effect and in the event of a conflict between any of the provisions of this Agreement and Attachment B to the Evaluation Agreement, the provisions of this Agreement shall govern.  For the avoidance of doubt, this Agreement does not supersede any existing generally applicable confidentiality agreement between the Parties as it relates to time periods prior to the date hereof or to business dealings not covered by this Agreement.  No term of this Agreement may be amended except upon written agreement of both Parties, unless otherwise expressly provided in this Agreement.

 

13.2        Captions; Certain Conventions.  The captions in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement.  Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (A) words of any gender include each other gender, (B) words such as “herein”, “hereof’, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (C) words using the singular shall include the plural, and vice versa, (D) the words “include(s)” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import, (E) the word “or” shall be deemed to include the word “and” (e.g., “and/or”), (F) references to “Article,” “Section,” “subsection,” “clause” or other subdivision, or to an Attachment or other appendix, without reference to a document are to the specified provision or Attachment of this Agreement and (G) all monetary amounts expressed herein shall be in U.S. dollars unless otherwise stated.  This Agreement shall be construed as if it were drafted jointly by the Parties.

 

13.3        Further Assurances.  The Parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

 

13.4        No Waiver.  Failure by either Party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

 

13.5        Severability.  If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect.

 

13.6        Independent Contractors.  The relationship of the Parties is that of independent contractors, and neither Party will incur any debts or make any commitments for the other Party except to the extent expressly provided in this Agreement.  Nothing in this Agreement is intended to create or will be construed as creating between the Parties the relationship of 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

25

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

joint ventures, co-partners, employer/employee or principal and agent.  Neither Party shall have any responsibility for the hiring, termination or compensation of the other Party’s employees or contractors or for any employee benefits of any such employee or contractor.

 

13.7        Successors and Assigns.  This Agreement will be binding upon and inure to the benefit of the Parties, their successors and permitted assigns.  Neither Party may assign this Agreement, in whole or in part, without the prior written consent of the other Party, except that either Party may, without the other Party’s consent (but subject to prior written notice), assign this Agreement in its entirety to an Affiliate or to a successor to substantially all of the business or assets of the assigning company or the assigning company’s business unit responsible for performance under this Agreement.

 

13.8        No Third Party Beneficiaries.  This Agreement shall not confer any rights or remedies upon any person or entity other than the Parties named herein and their respective successors and permitted assigns.

 

13.9        Governing Law.  This Agreement shall be governed by and construed under the laws of the State of Delaware, USA, excluding its conflicts of law provisions.  The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

 

13.10      Alternative Dispute Resolution.  Any dispute arises between the Parties in connection with this Agreement shall first be presented to the respective senior executives of the Parties for their consideration and resolution.  If such Parties’ executives cannot resolve such dispute within ninety (90) days, then such dispute shall be submitted to arbitration by the International Institute for Conflict Prevention and Resolution, 575 Lexington Avenue, 21st Floor, New York, NY 10022 (“CPR”) by one arbitrator mutually agreed upon by the Parties.  If no agreement can be reached within thirty (30) days after names of potential arbitrators have been proposed by the CPR, then the CPR will choose one arbitrator having reasonable experience in commercial transactions of the type provided for in this Agreement.  The arbitration shall take place in the English language in New York City, New York, in accordance with the CPR administered arbitration rules then in effect, and judgment upon any award rendered in such arbitration will be binding and may be entered in any court having jurisdiction thereof.  The arbitration shall commence within sixty (60) days of the date on which a written demand for arbitration is filed.  The arbitrator’s decision shall set forth a reasoned basis for any award of damages or finding of liability.  The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages.  The arbitrator shall award to the prevailing party, if any, the costs and attorneys’ fees reasonably incurred by the prevailing party in connection with the arbitration.

 

13.11      Publicity.  Neither Party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other Party’s express prior written consent, except as required under Applicable Laws or by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing Party are listed, in which case the Party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

26

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.  Without limiting the generality of the foregoing, Client shall not use Catalent’s name in a manner that could be construed as an endorsement of Client’s Drug, including any scientific conclusion as to safety or efficacy.

 

13.12      Right to Dispose and Settle.  If Catalent requests in writing from Client direction with respect to disposal of any inventories of Supplies, Client-supplied Materials, Drug, equipment, samples or other items belonging to Client and is unable to obtain a response from Client within a reasonable time period after making reasonable efforts to do so, Catalent shall be entitled in its sole discretion to (A) dispose of all such items and (B) set-off any and all amounts due to Catalent or any of its Affiliates from Client against any credits Client may hold with Catalent or any of its Affiliates.

 

13.13      Force Majeure.  Except as to payments required under this Agreement, neither party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such party’s performance hereunder if such default or delay is caused by events beyond such party’s reasonable control, including acts of God, law or regulation or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire, flood or weather, labor disturbances, epidemic or failure of suppliers, vendors, public utilities or common carriers; provided, that the party seeking relief under this Section 13.13 shall immediately notify the other party of such cause(s) beyond such party’s reasonable control.  The party that may invoke this Section 13.13 shall use commercially reasonable efforts to reinstate its ongoing obligations to the other party as soon as practicable.  If the cause(s) shall continue unabated for 180 days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from such cause(s).

 

13.14      Counterparts.  This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument.  Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

 

[Signature page follows]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

27

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

IN WITNESS WHEREOF, the Parties have caused their respective duly authorized representatives to execute this Agreement effective as of the Effective Date.

 

	
 
    	
CATALENT U.K. SWINDON ZYDIS   LIMITED
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ B. Littlejohns
    
	
 
    	
 
    	
Name:
    	
B. Littlejohns
    
	
 
    	
 
    	
Title:
    	
President DDS
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
BIOHAVEN PHARMACEUTICAL HOLDING   COMPANY LTD
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Robert Berman
    
	
 
    	
 
    	
Name:
    	
Robert Berman, MD
    
	
 
    	
 
    	
Title:
    	
Chief Medical Officer
    

 

Signature Page to Zydis® Development and License Agreement

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

ATTACHMENT A

 

DEVELOPMENT PROGRAM

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Catalent Pharma Solutions, LLC and Biohaven Pharmaceutical Holding
 Company Limited Zydis® Terms and Conditions for Riluzole

 

A.                  Expiration.  This Quotation is valid for 30 days from the date hereof, and becomes binding if signed and delivered by both parties during that period.

 

B.                  Audits.  Client may conduct one quality assurance facility audit every [* * *] months at no cost.  Additional audits will be invoiced separately at the current rate for such services.

 

C.                  Regulatory Inspections.  Catalent will promptly notify Client of any regulatory inspections directly relating to the services performed under this Quotation (the “Project”).  Client shall reimburse Catalent for reasonable and documented costs associated with such regulatory inspections.

 

D.                  Changes.  Catalent may revise the prices provided in this Quotation (i) if Client’s requirements or any Client-provided information is materially inaccurate or incomplete; (ii) if Client revises Catalent’s responsibilities or the Project specifications, instructions, procedures, assumptions, processes, test protocols, test methods or analytical requirements; or (iii) for such other reasons set forth in this Quotation.  Any revision to this Quotation shall be set forth in a Quotation Amendment Request (“QAR”) signed by both Parties in accordance with Section V.

 

E.                   Payments.  Catalent will invoice Client as set forth in this Quotation.  Catalent charges a late payment fee of [* * *]% per month for payments not received by the date specified in this Quotation (or if no date is specified, within 30 days of invoice date).  Failure to bill for interest due shall not be a waiver of Catalent’s right to charge interest.

 

F.                    Taxes.  All sales, use, gross receipts, compensating, value-added or other taxes, duties, licenses or fees (excluding Catalent’s net income and franchise taxes) assessed by any tax jurisdiction arising from the Project are the responsibility of Client, whether paid by Catalent or Client.

 

G.                  Hazardous Materials.  Client warrants to Catalent that no specific safe handling instructions are applicable to any Client-supplied materials, except as disclosed to Catalent in writing by the Client in sufficient time for review and training by Catalent prior to delivery.  Where appropriate or required by law, Client will provide a Material Safety Data Sheet for all Client-supplied materials and finished product.

 

H.                 Delivery.  (i) Catalent shall deliver all products and other materials EXW (Incoterms 2010) Catalent’s facilities.  To the extent not already held by Client, title shall pass to Client upon such tender of delivery.  If Catalent provides storage services, title and risk of loss shall pass to client upon transfer to storage.

 

(ii) In the event Catalent arranges shipping or performs similar loading and/or logistics services for Client at Client’s request, such services are performed by

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Catalent at Client’s expense and on Client’s behalf as a convenience to Client only and does not alter subsection (i) above.

 

I.                      Limitations of Liability.  CATALENT’S TOTAL LIABILITY UNDER THIS QUOTATION SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS QUOTATION OR QAR, RESPECTIVELY (BUT EXCLUDING FEES AND COSTS FOR PROCURING COMPARATOR DRUG).  CATALENT SHALL HAVE NO LIABILITY UNDER THIS QUOTATION OR QAR FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT INCORPORATED INTO FINISHED PRODUCT. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS QUOTATION OR QAR, INCLUDING WITHOUT LIMITATION LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. NOTHING IN THIS QUOTATION SHALL LIMIT THE LIABILITY OF CATALENT FOR DEATH OR PERSONAL INJURY ARISING FROM THE NEGLIGENCE OF CATALENT, THE LIABILITY OF CATALENT FOR FRAUDULENT MISREPRESENTATION OR ANY OTHER MATTER FOR WHICH IT WOULD BE ILLEGAL FOR CATALENT TO EXCLUDE OR ATTEMPT TO EXCLUDE LIABILITY.

 

J.                      Confidentiality.  All information disclosed by a party in connection with this Quotation shall be confidential information, unless such information is (i) already known to the receiving party, on a non-confidential basis, as evidenced by written records; (ii) independently developed or discovered by the receiving party without the use of the disclosing party’s confidential information, as evidenced by written records; (iii) in the public domain, other than through the fault of the receiving party; (iv) disclosed to the receiving party by a third party not in breach of a duty of confidentiality owed to the disclosing party.  Neither party shall, without the other party’s prior written consent, use the confidential information of the other party or disclose such information except (a) to provide to employees of the receiving party or its affiliated entities who require such information to perform such party’s obligations under this Quotation, or (b) as required to be disclosed by law, or court or administrative order, provided that the receiving party first gives prompt written notice thereof to the disclosing party.  This undertaking shall survive for [* * *] years following the date of this Quotation.  The data and results of the Project (the “Project Results”) shall be the property of Client and shall be deemed confidential information of Client.  Catalent may request permission to use any Project Results which permission will not be unreasonably withheld.

 

K.                  Intellectual Property.  For purposes hereof, “Intellectual Property” means all intellectual property (whether or not patented), including without limitation, patents, patent applications, know-how, trade secrets, copyrights, trademarks, designs, concepts, technical information, manuals, standard operating procedures, instructions, specifications, inventions, processes, data, improvements and developments; and “Inventions” means Intellectual Property characterized, conceived, developed, derived, discovered, generated, identified, first reduced to

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

3

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

practice or otherwise made, as the case may be, by employees, servants or agents of Client and/or Catalent in connection with this Project.  All rights to and interests in Intellectual Property that is owned by, licensed to or otherwise controlled by a party or its affiliates (A) as of the date of this Quotation or (B) except as provided below in this Section K, at any time following the date of this Quotation, shall remain vested solely in such party and the other party will obtain no right of any kind or license therein by reason of this Quotation, except that Catalent shall have the right to use such Intellectual Property of Client to the extent required in connection with the performance of its obligations hereunder.  As between Client and Catalent, all Inventions shall be (A) the property of Client if the Invention specifically relates to Client’s compounds [* * *] and formulations thereof, (B) the property of Client if the Invention relates to the application or use of [* * *] (for example, [* * *]), and (c) the property of Catalent in all other circumstances, including Inventions relating specifically to the Zydis Technology, except to the extent that such Invention is specifically related to [* * *].  The party owning such Invention shall have the right, in its sole discretion, to determine the patent strategy for such Invention, which may include not obtaining patent protection in a particular country or any country.  The parties shall cooperate to achieve the allocation of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection of its Intellectual Property.  Catalent and its Affiliates have developed and licensed proprietary technology for the manufacture of the patented Zydis® Fast Dissolving Dosage Form (“Zydis”) for the administration of pharmaceutical drugs (collectively, along with the Zydis Patents and all know-how, data, results and information relating to Zydis and the Zydis Patents (whether produced prior to or after the Effective Date), the “Zydis Technology”.  “Zydis Patents” mean the valid and issued patents and pending patent applications (until such time as such applications or any of them are denied, abandoned or issued into patents), and any foreign cognates, divisional, continuation, continuation-in-part, reissue, re-examination, extension, patent of addition, provisional applications, confirmation patent, registration patent, pipeline protection or supplementary protection certificate related thereto, that include claims relating to fast dissolving drug delivery systems, that Catalent or its Affiliates own or under which Catalent or its Affiliates are licensed with the right to sublicense.  [* * *].  The parties acknowledge that Catalent shall have no right to use [* * *], that Client is not granted any rights to the Zydis Technology, and that any use of [* * *] by Client may require a license from Catalent to make, use, sell or produce any such [* * *].

 

L.                   Warranties.  Catalent will perform the Project in accordance with the written specifications and Project instructions expressly set forth or referenced in this Quotation and United States current Good Manufacturing Practices.  THE WARRANTIES SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY CATALENT TO CLIENT, AND CATALENT MAKES NO OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

M.               Client Obligations.  Unless otherwise agreed to by the parties in writing, Client is solely responsible at its cost and expense to (i) provide complete and accurate scientific data regarding the Project; (ii) deliver to Catalent all Client-supplied materials; (iii) prepare all submissions to regulatory authorities and obtain Catalent’s prior written consent (which will not be unreasonably withheld) before identifying Catalent in such regulatory submissions; (iii) if applicable, review and approve all in-process and finished product test results to ensure conformity of such results with the product specifications, regardless of which party is responsible for finished product release; and (iv) perform such other obligations of Client set forth in this Quotation.

 

N.                  Regulatory Compliance.  Catalent shall obtain and maintain all permits and licenses with respect to general facility operations in the jurisdiction in which Catalent performs the services.  Client shall be responsible at its cost to obtain and maintain all other regulatory approvals, authorizations, certifications and permits relating to Client-supplied materials and Client product, including without limitation those relating to the import, export, use, distribution and sale of Client-supplied materials and Client product.  Client shall reimburse Catalent for any payments Catalent is required to make to any regulatory authority resulting directly from Catalent’s formulation, development, manufacturing, processing, filling, packaging, storing or testing of Client’s product or Client-supplied materials (including without limitation any payments or fees Catalent is required to make pursuant to the Generic Drug User Fee Act of 2012).  Catalent shall not be obligated to perform any services which would involve any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or United States.

 

O.                  Indemnification.  Client will indemnify, defend and hold harmless Catalent, its affiliates and their respective directors, officers, employees and agents against any third-party claim arising directly or indirectly from (i) the manufacture, promotion, marketing, distribution or sale of, or use of or exposure to, the product, API and Client-supplied materials that are the subject of the Project; (ii) the negligence or willful misconduct of Client; (iii) the breach of this Quotation by Client; or (iv) the use of any intellectual property, materials or other information provided by Client to Catalent; in each case, including but not limited to costs associated with responding to subpoenas and giving testimony relating to disputes between Client and third parties.  Catalent will indemnify, defend and hold harmless Client, its affiliates and their respective directors, officers, employees and agents from any third-party claim arising directly or indirectly from the negligence or willful misconduct of Catalent or the breach of this Quotation by Catalent.

 

P.                    Right to Dispose and Settle.  If Catalent requests in writing from Client direction with respect to disposal of products, materials, equipment, samples or other items belonging to Client and is unable to obtain a response from Client within a reasonable time period (but in no event less than [* * *] days) after making reasonable efforts to do so, Catalent may in its sole discretion (i) dispose of all such items and (ii) set-off any and all amounts due to Catalent or any of its affiliates from Client against any credits Client may hold with Catalent or any of its affiliates.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Q.                  Force Majeure.  Neither party will be liable for any failure to perform or for delay in performance resulting from any cause beyond its reasonable control, including without limitation acts of God, fires, floods or weather, strikes or lockouts, factory shutdowns, embargoes, wars, hostilities or riots, or shortages in transportation.  If the cause continues unabated for 90 days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Quotation should result from such cause.

 

R.                  Use and Disposal.  Client represents and warrants to Catalent that Client will hold, use and/or dispose of products and other materials provided by Catalent in accordance with all applicable laws, rules and regulations.  Client grants Catalent full authority to use any Client-supplied materials for purposes of the Project.

 

S.                    Record Retention.  Unless the parties otherwise agree in writing, Catalent will retain batch, laboratory and other technical records for the minimum period required by applicable law.

 

T.                   Independent Contractor.  The relationship of the parties is that of independent contractors and not of joint venturers, co-partners, employer/employee or principal/agent.

 

U.                  Publicity.  Neither party will make any press release or other public disclosure regarding this Quotation or the transactions contemplated hereby without the other party’s express prior written consent, except as required by applicable law, by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or public disclosure.

 

V.                  Amendment & Precedence.  These Terms and Conditions constitute a part of the Quotation to which they are attached (collectively, “this Quotation”); provided, that these Terms and Conditions supersede any conflicting terms and conditions set forth in the Quotation to which they are attached or any other document, including Client purchase order.  This Quotation constitutes the entire understanding between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties, with respect to the Project.  No term of this Quotation may be amended except upon written agreement signed by both parties.

 

W.               Dispute Resolution.  If a dispute arises between the parties in connection with this Quotation, the respective presidents or Senior Executives of Catalent and Client shall first attempt to resolve the dispute.  If such parties cannot resolve the dispute, such dispute shall be resolved by the International Institute for Conflict Prevention and Resolution (“CPR”), 575 Lexington Avenue, 21st Floor, New York, NY 10022 in accordance with CPR’s then existing commercial arbitration rules.  The arbitration proceedings shall be conducted in New York, New York and the exclusive language of the proceedings shall be English.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

X.                  Survival.  Subject to execution, the rights and obligations of Client and Catalent in Articles E, F, I, J, K, O, S, U, W, X and Y of these Terms and Conditions shall survive termination or expiration of this Quotation.

 

Y.                  Governing Law.  This Quotation shall be governed by and construed under the laws of the State of New Jersey, USA, excluding its conflict of law provisions.  The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Quotation.

 

Z.                   Clinical and Regulatory.  Within [* * *] months after the execution of this Quotation, but in any event prior to the delivery by Catalent of any supplies required to be manufactured in accordance with cGMP, including supplies to be used in human clinical trials, the parties shall negotiate in good faith and enter into a Quality Agreement.  In the event of a conflict between any of the provisions of this Quotation and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern.  In the event of a conflict between any of the provisions of this Quotation and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Quotation shall govern.  Client shall be responsible for conducting any activities relating to the planning and execution of pre-clinical and clinical studies in animals or humans and for preparing and filing regulatory submissions with respect thereto, including any costs associated therewith.  Client shall obtain and maintain all necessary regulatory approvals and to comply with all applicable laws and regulations in this respect, including filing all periodic reports, safety reports, and all other notifications as required by the regulatory authorities.  Client shall be responsible for retaining and maintaining all study records, financial information, and reserve samples, as required under applicable laws generated or used in the execution of the pre-clinical and clinical studies in animals or humans performed in connection with this Quotation.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

7

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

 

Why Catalent?

 

Unrivaled experience, deepest expertise, and a track record of market success on a global scale.

 

We serve 49 of the top 50 pharmaceutical and 36 of the top 50 biotech companies.

 

We support thousands of innovative prescription, generics, and consumer health companies.

 

We operate 20+ global sites across 100+ markets.

 

We create expert solutions from over 1,000 scientists, including key opinion leaders in drug development and delivery.

 

We support 40% of recent new U.S. drug approvals.

 

We manufacture or package 100 billion units annually.

 

We are the industry leader in drug delivery technology.

 

We use a multi-faceted approach to solve bioavailability and patient adherence challenges.

 

We provide end-to-end biologics technologies, from gene expression to fill/finish.

 

We offer fully-integrated medication supply chain solutions.

 

We have a proven track record in regulatory compliance in all key jurisdictions.

 

We are fully dedicated to high standards of quality, cGMP leadership, and LEAN operational excellence.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

8

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

9

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

ATTACHMENT B

 

FORM OF QUALITY AGREEMENT

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

	
 
    	
 
    
	
 
    	
 
    

 

Quality Agreement

 

Between

 

CUSTOMER

 

And

 

Catalent Pharma Solutions, LLC
 14 Schoolhouse Road
 Somerset, NJ 08873

 

With Offices At

 

	
 
    	
 
    	
 
    	
 
    
	
Site   address
    	
 
    	
 
    	
Site   address
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    

For Product
  (add product name or refer to product list in appendix)
  Effective dates from month/year to month year
 Next Review add month/year

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

This Quality Agreement has been reviewed, approved, and accepted by:

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name
    	
 
    	
Date
    	
 
    	
Name
    	
 
    	
Date
    
	
Company Name
    	
 
    	
 
    	
 
    	
Company Name
    	
 
    	
 
    
	
Company Address
    	
 
    	
 
    	
 
    	
Company Address
    	
 
    	
 
    
	
Email Address
    	
 
    	
 
    	
 
    	
Email Address
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Additional names of signatories   as needed
    	
 
    	
Date
    	
 
    	
Additional names of signatories   as needed
    	
 
    	
Date
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Additional names of signatories   as needed
    	
 
    	
Date
    	
 
    	
Additional names of signatories   as needed
    	
 
    	
Date
    

 

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Quality Agreement

 

This is a Quality Agreement for the PRODUCT: add product name or list products in Appendix Il (this “Quality Agreement”).  This Quality Agreement defines the duties of Catalent Pharma Solutions, LLC (CATALENT) and (CUSTOMER) for the pharmaceutical manufacturing and packaging of PRODUCT. This Quality Agreement applies to clinical/submission batches prior to product commercialization.  A separate Quality Agreement will be executed for commercialization.

 

This Quality Agreement takes the form of a detailed checklist of all the activities associated with pharmaceutical manufacturing, release testing, and stability testing of Product.  Responsibility for each activity is assigned to either CATALENT or CUSTOMER in the appropriate box in the Responsibility Delegation Checklist, which follows.  Activities and/or requirements assigned to both Catalent and the Customer means that both parties will be responsible for carrying out the referenced activity or meeting the listed requirement.  For example, the following requirement, “Is not debarred and does not employ or use the services of any individual who is debarred” would apply to both the customer and Catalent and both responsibility boxes would be checked off.  If both Customer and Catalent activity/responsibility boxes are checked off but the referenced activity/responsibility does not equally apply to both the Customer and Catalent, the relevant activities/responsibilities applying to the customer and to Catalent shall be denoted in the respective box.

 

In order to provide better quality assurance, CATALENT will perform the activities defined herein in accordance with Standard Operating Procedures (defined below) to the extent that a Standard Operating Procedure is applicable to such activity.  In the event of a conflict between the terms of this Quality Agreement and a Standard Operating Procedure, the Quality Agreement shall control.  This Quality Agreement is subject to the terms of a Services Agreement (defined below).  In the event of a conflict between the provisions of this Quality Agreement and the Services Agreement with respect to quality-related activities outlined in this Quality Agreement, including responsibility for compliance with cGMP, this Quality Agreement shall control.  In the event of a conflict between the Services Agreement and this Quality Agreement relating to allocation of risk, financial responsibility and liability, the provisions of the Services Agreement shall control.

 

For purposes of this Quality Agreement, the following definitions shall apply:

 

A.                        “Aberrant/Atypical Data” means any data or result that is still within specification, but is unexpected, questionable, irregular, deviant or abnormal.

 

B.                        “Active Pharmaceutical ingredient” (API) shall mean the active pharmaceutical ingredient used in the manufacture of the Product as identified in the Specifications.

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

C.                        “Applicable Laws” means, with respect to CUSTOMER, all laws, ordinances, rules and regulations, as amended from time to time, of each jurisdiction in which API or Product is produced, marketed, distributed, used or sold; and with respect to Catalent, all laws, ordinances, rules and regulations, as amended from time to time, of the jurisdiction in which Catalent performs the services.

 

D.                        “Certificate of Analysis” (COA) is a listing of all results for tests conducted on samples of a lot of product compared to the specifications defined by the CUSTOMER and listed in the regulatory applications and application compendia.

 

E.                         “Certificate of Compliance/Conformance” (COC) is a statement that the lot of product was manufactured, packaged and tested in accordance with cGMP, identifies the master batch record documents and lists any incident reports and investigations identified associated with the lot of Product.

 

F.                          “Controlled Drug Substances” (CDS) is any drug, or therapeutic agent, commonly understood to include narcotics with a potential for abuse or addiction, which is held under strict governmental control, as defined by the United States Controlled Substances Act, 21 U.S.C. 802 et seq.

 

G.                        “Code of Federal Regulations (USA)” (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.  It is divided into 50 titles that represent broad areas subject to Federal regulation.  Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

 

H.                       “Current Good Manufacturing Practice” (cGMP) means current Good Manufacturing Practices promulgated by the Regulatory Authorities in the jurisdictions included in Applicable Laws (as applicable to CUSTOMER and Catalent, respectively).  In the European Union, this includes Directive 2003/94/EC (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended, if and as implemented in the relevant constituent country, and in the United States, this includes 21 C.F.R. Parts 210 and 211, as amended.

 

I.                            “Debarred” shall mean the penalty imposed by the US FDA pursuant to 21 USC 335a (a) or 335a (b) on persons or companies that have engaged in criminal conduct with respect to the development or approval of new or generic drugs or engaged in certain other types of criminal conduct.  A debarred person or company is precluded from submitting or assisting in the submission of an NDA or ANDA and may not provide services in any capacity to a party that has an approved or pending drug application.

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

J.                            “For Cause Audit” shall mean any of a series of inspections conducted for various compelling reasons (questionable data in a final report, tips from informers, etc.).

 

K.                        “Drug Enforcement Administration” (DEA) is the US federal agency responsible for enforcing laws and regulations governing narcotics and controlled substances.

 

L.                         “Excipients” shall mean the inactive ingredients found in a drug product.  These include dyes, flavors, binders, emollients, fillers, lubricants, and preservatives.

 

M.                     “Facilities” means the following Catalent facilities located at:

 

	
Facility
    	
 
    	
Service
    
	
List each facility (name, address)
    	
 
    	
List services the facility is providing
    
	
 
    	
 
    	
 
    
	
List each facility (name, address)
    	
 
    	
List services the facility is providing
    
	
 
    	
 
    	
 
    
	
List each facility (name, address)
    	
 
    	
List services the facility is providing
    

 

N.                        “Marketing Authorization Application” shall mean any application for marketing authorization, which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application (NDA), FDA Abbreviated New Drug Application (ANDA) and similar marketing applications promulgated by Regulatory Authorities.

 

O.                        “Marketing Authorizations” shall mean any approved application for marketing authorization, including without limitation, FDA New Drug Application (NDA), FDA Abbreviated New Drug Application (ANDA) and similar marketing authorizations promulgated by Regulatory Authorities.

 

P.                          “Out of Specification” (OOS) shall mean a result that falls outside of the test’s acceptance criteria (e.g. criteria established in filed applications, approved marketing submissions, official compendia, or by the manufacturer or the customer).

 

Q.                        “Out of Tolerance” shall mean a calibration result that is outside of the instrument’s specified performance limits.

 

R.                        “Out of Trend” shall mean a result that is not in trend with previously acquired results.  This will typically apply to either stability projects when comparisons 

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

are made with previous intervals or to release testing when a substantial testing history has been generated.

 

S.                          “Packaging Materials” shall mean collectively all packaging components and ingredients (including labels, product inserts, and other labeling for Products) required to package the Products in accordance with the specifications.

 

T.                         “Process” or “Processing” shall mean the compounding, filling, producing and/or packaging of the Raw Materials into Product in accordance with the Specifications.  Such activities include the requisite in-process analytical testing and inspections.

 

U.                        “Product” shall mean such drug product being manufactured and/or packaged by Catalent pursuant to a Services Agreement.  The term “Product” shall comprise both “Bulk Product” and “Finished Product” where Bulk Product means such Product which has completed all parts of the Process up to but not including final packaging and where Finished Product shall mean Product which has undergone all stages of the Process including packaging in its final container.

 

V.                        “Raw Materials” shall mean all raw materials, supplies, components and packaging materials, not including the API, necessary to process, bulk package and ship the Product in accordance with specifications.

 

W.                     “Regulatory Authority” shall mean the FDA and any other regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

 

X.                        “Reprocessing” shall mean the duplication of a step or steps currently in the manufacturing formula in order to bring the batch into conformance with specifications, and which will not alter the safety, identity, strength, quality or purity of the drug product beyond the established requirements.

 

Y.                        “Rework” shall mean any additional steps that are not part of the manufacturing formula, taken to process a batch to bring the batch into conformance with the specifications and which will not alter the safety, identity, strength, quality or purity of the drug product beyond the established requirements.

 

Z.                         “Services Agreement” shall mean the agreement entered into between Catalent and Customer which sets forth the terms and conditions agreed between the parties governing the provision of services by Catalent on behalf of Customer, including but not limited to supply agreements, standard or negotiated terms and conditions, master clinical or commercial services

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

agreements, development and manufacturing agreements (collectively referred to herein as “Services Agreement”).

 

AA.               “Specifications” shall mean the written specifications for the Product set forth in the Services Agreement and attached hereto as an Exhibit.

 

BB.               “Standard Operating Procedures” (SOP) shall mean the standard operating procedures in effect at Catalent which have been approved by Catalent Quality Assurance department and which are applicable to the Processing.  The Standard Operating Procedures shall be in compliance with cGMP.

 

CC.               “Territories” shall mean the United States of America [and the European Union] and any other country, which the parties agree in writing to add to this Quality Agreement and the Services Agreement from time to time.

 

DD.               “US Food and Drug Administration” (FDA) is an agency of the United States Department of Health and Human Services responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, foods, cosmetics, and products that emit radiation.

 

	
Confidential
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

RESPONSIBILITY DELEGATION CHECKLIST

 

	
RESPONSIBILITIES
    	
 
    	
CUSTOMER
    	
 
    	
CATALENT 
   Manufacturing 
   Site
    	
 
    	
CATALENT 
   Packaging Site
    	
 
    	
CATALENT 
   Testing Site
    
	
1.
    	
 
    	
Regulatory Authorizations & GMP   Compliance
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[* * *]
    	
 
    	
[* * *]
    	
 
    	
[* * *]
    	
 
    	
[* * *]
    	
 
    	
[* * *]
    	
 
    	
[* * *]
    

 

	
Confidential
    	
 
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

APPENDIX I

 

KEY CONTACT INFORMATION

 

CATALENT

 

	
Contact Person
    	
 
    	
Address
    	
 
    	
Numbers
    	
 
    	
Email Address
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title: Director, QA
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title: Testing Labs
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title: Project Manager
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title: Technical Services
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    

 

CUSTOMER

 

	
Contact Person
    	
 
    	
Address
    	
 
    	
Numbers
    	
 
    	
Email Address
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title: Director, QA
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
 
    	
P:
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
 
    	
F:
    	
 
    	
 
    

 

	
Confidential
    	
 
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

APPENDIX II

 

Products Covered By Quality Agreement

 

This Quality Agreement covers the following products:

 

	
Product Name
    	
 
    	
 
    
	
API Source
    	
 
    	
Product Code/Identifier
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    

 

QUALITY AGREEMENT REVISION HISTORY

 

	
Version
   Number
    	
 
    	
Description of Document Revision
    	
 
    	
Date
    
	
0.0
    	
 
    	
New Version
    	
 
    	
Jun 2013
    

 

	
Confidential
    	
 
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

ATTACHMENT C

 

COMMERCIAL SUPPLY TERMS

 

THIS ATTACHMENT C INCLUDES CERTAIN TERMS TO BE INCLUDED IN A SUPPLY AGREEMENT BETWEEN CLIENT AND CATALENT. THE TERMS INCLUDED ARE NOT INTENDED TO BE EXHAUSTIVE. CATALENT OR ITS COUNSEL WILL PREPARE THE INITIAL DRAFT OF THE SUPPLY AGREEMENT. ANY AGREEMENT RELATING TO THE SUBJECT MATTER HEREOF SHALL BE SUBJECT AMONG OTHER THINGS TO THE NEGOTIATION AND EXECUTION OF A DEFINITIVE SUPPLY AGREEMENT BETWEEN CLIENT AND CATALENT.

 

·                  If Catalent refuses or are unable to manufacture any of the Products for whatever reason, other than force majeure, Client may seek alternate manufacturers, subject to Client obtaining the necessary license for the additional rights to make or have made the Product, which shall be negotiated in good faith by the Parties.

 

·                  Catalent will, at Client’s request and expense, fully transfer, qualify, and validate all manufacturing and testing of each Product to a second Catalent facility, or at Catalent’s discretion, a third party facility acceptable to Client, within [* * *] months of the first regulatory approval in the Territory.

 

·                  In addition, Catalent shall put a description of its Zydis Technology reasonably sufficient for a third party to manufacture the Products in a technology escrow to be released to a third party only in the event that Catalent is unable or unwilling to manufacture the Products for Client at a Catalent facility or a qualified third-party facility.

 

·                  Product per tablet cost to Client from Catalent shall be between $[* * *] and $[* * *] including COG, costs of manufacturing and primary unit dose packaging, but excluding the cost of Drug.

 

·                  For any Products sold or supplied by Catalent, Catalent will represent and warrant to Client that the Products shall be manufactured in accordance with Applicable Laws and cGMP, shall comply with the applicable specifications, and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws and cGMP; provided, that Catalent shall not be liable for defects attributable to Client-supplied materials (including artwork, advertising and labeling), provided further, that Catalent shall not utilize any debarred person in the supply, manufacture, packaging or labeling of any Product for Client.

 

·                  Catalent agrees to properly pack, label and deliver Products Ex Works (Incoterms 2010) in accordance with Applicable Laws and Catalent’s standard procedures.

 

·                  Client shall be granted access upon at least [* * *] business days’ prior notice, at reasonable times during regular business hours, to inspect the portion of

 

	
Confidential
    	
 
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Catalent’s facility where Catalent processes the Products and to the relevant personnel performing services for Client.  Client may not conduct such an inspection audit more than [* * *] during any 12-month period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning the Products.

 

	
Confidential
    	
 
    	
CPS-QP-1125 —F01   Version 1.0
    

CUSTOMER & Catalent Pharma Solutions Quality Agreement

Month/Year

Page x of xx

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.Exhibit 10.6

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

THE GENERAL HOSPITAL CORPORATION

 

EXCLUSIVE PATENT LICENSE AGREEMENT

 

MGH Agreement No: 221771

MGII Case No: 21125

 

This License Agreement (“Agreement”) is made as of the 13 day of September, 2014 (“Effective Date”), by and between BioHaven Pharmaceutical Holding Company, a British Virgin Island corporation, having a principal place of business at Suite 304 / 234 Church Street / New Haven CT 06510 (“Company”) and The General Hospital Corporation, d/b/a Massachusetts General Hospital, a not-for-profit Massachusetts corporation, with a principal place of business at 55 Fruit Street, Boston, Massachusetts 02114 (“Hospital”), each referred to herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

Hospital, as a center for patient care, research and education, is the owner of certain Patent Rights (defined below) and desires to grant a license of those Patent Rights to Company in order to benefit the public by disseminating the results of its research via the commercial development, manufacture, distribution and use of Products and Processes (defined below).

 

Company has the capability to commercially develop, manufacture, distribute and use Products and Processes for public use and benefit and desires to license such Patent Rights.

 

For good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

1.  CERTAIN DEFINITIONS

 

As used in this Agreement, the following terms shall have the following meanings, unless the context requires otherwise.

 

1.1                               “Affiliate” with respect to either Party shall mean any corporation or other legal entity other than that Party in whatever country organized, controlling, controlled by or under common control with that Party. The term “control” shall mean (i) in the ease of Company, direct or indirect ownership of fifty percent (50%) or more of the voting securities having the right to elect directors, and (ii) in the case of Hospital, the power, direct or indirect, to elect or appoint fifty percent (50%) or more of the directors or trustees, or to cause direction of management and policies, whether through the ownership of voting securities, by contract or otherwise.

 

1.2                               “Claim” shall mean any pending or issued claim of any Patent Right that has not been permanently revoked, nor held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal.

 

“Change of Control” shall mean (a) a merger or consolidation of the Company with or into any other entity or (b) the sale, conveyance or other disposition of all or substantially all of the Company’s assets.

 

1.3                               “Distributor” shall mean any third party entity to whom Company, a Company Affiliate or a Sublicensee has granted, express or implied, the right to distribute any Product or Process pursuant to Section 2.1(b)(ii).

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.4                               “First Commercial Sale” shall mean the initial Sale anywhere in the applicable License Territory of a Product or Process.

 

1.5                               “License Field” shall mean therapeutics for any INDICATION of the central nervous system in humans.

 

1.6                               “INDICATION(S)” shall mean any indication bearing a distinct reference number under the list of diseases officially published by the World Health Organization (WIN)) or list of disorders published in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM 5, or above) or such successor organizations that are in effect at the relevant time during the term of this Agreement.

 

1.7                               “License Territory” shall mean worldwide.

 

1.8                               “Net Sales” shall be calculated as set forth in this Section 1.7.

 

(a)                                 Subject to the conditions set forth below, “Net Sales” shall mean:

 

(i)                                     the gross amount billed or invoiced, or if no such bill or invoice is issued the amount received, whichever is greatest, by Company and its Affiliates and Sublicensees for or on account of Sales of Products and Processes;

 

(ii)                                  less the following amounts:

 

(A)                               to the extent separately stated on the bill or invoice, [* * *]:

 

1.                                      amounts repaid or credited [* * *];

 

2.                                      reasonable and customary [* * *] rebates or discounts [* * *];

 

3.                                      amounts for outbound transportation, insurance, handling and shipping, [* * *]; and

 

4.                                      taxes, customs duties and other governmental charges [* * *].

 

5.                                      unpaid accounts or bad debt [* * *]

 

(B)                               [* * *].

 

(b)                                 Specifically excluded from the definition of “Net Sales” are amounts attributable to any Sale of any Product or Process between or among Company and any Company Affiliate and/or Sublicensee, unless the transferee is the end purchaser, user or consumer of such Product or Process.

 

(c)                                  No deductions shall be made for any commissions paid to any individuals or for any costs or expenses of collections.

 

(d)                                 Net Sales shall be deemed to have occurred and the applicable Product or Process “Sold” on the earliest of the date of billing, invoicing, delivery or payment or the due date for payment.

 

(e)                                  If any Product or Process is Sold at a discounted price that is lower than the customary price charged, or for non-cash consideration (whether or not at a discount), Net Sales shall be

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

calculated based on [* * *]. Non-cash consideration that could affect any payment due to Hospital hereunder shall not be accepted without the prior written consent of Hospital.

 

1.9                               “Patent Rights” shall mean, inclusively, the U.S. Patent Application number Hospital’s rights in the U.S. provisional patent application number [* * *], filed on [* * *] and PCT Patent Application number [* * *], filed on [* * *] and/or the equivalent of such application including any division, continuation (but not including continuation-in-part), foreign patent application, Letters Patent, and/or the equivalent thereof issuing thereon, and/or reissue, reexamination or extension thereof, as may be further described in Appendix A.

 

1.10                        “Process” shall mean any process, method or service the use or performance of which, in whole or in part:

 

(a)                                 absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; or

 

(b)                                 employs, is based upon or is derived from Technological Information.

 

1.11                        “Product” shall mean any article, device or composition, the manufacture, use, or sale of which, in whole or in part:

 

(a)                                 absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; or

 

(b)                                 employs, is based upon or is derived from Technological Information.

 

1.12                        “Reporting Period” shall mean each three month period ending March 31, June 30, September 30 and December 31.

 

1.13                        “Sell” (and “Sale” and “Sold” as the case may be) shall mean to sell or have sold, to lease or have leased, to import or have imported or otherwise to transfer or have transferred a Product or Process for valuable consideration (in the form of cash or otherwise), and further in the case of a Process to use or perform such Process for the benefit of a third party.

 

1.14                        “Sublicense Income” shall mean consideration in any form received by Company and/or Company’s Affiliate(s) in connection with or otherwise attributable to a grant of a sublicense or any other right, license, privilege or immunity (regardless of whether such grantee is a “Sublicensee” as defined in this Agreement) to make, have made, use, have used, Sell or have Sold Products or Processes, but excluding consideration included within Net Sales. Sublicense Income shall include without limitation any license signing fee, license maintenance fee, unearned portion of any minimum royalty payment, distribution or joint marketing fee, research and development funding in excess of the cost of performing such research and development, and any consideration received for an equity interest in, extension of credit to or other investment in Company or Company’s Affiliates to the extent such consideration exceeds the fair market value of the equity or other interest received as determined by agreement of the Parties or by an independent appraiser mutually agreeable to the Parties.

 

1.15                        “Sublicensee” shall mean any sublicensee of rights granted in accordance with Section 2.1(a)(ii). For purpose of this Agreement, a Distributor of a Product or Process shall not be included in the definition of Sublicensee unless such Distributor (i) is granted any right to make, have made, use or have used Products or Processes in accordance with Section 2,1(a)(ii), or (ii) has agreed to pay to Company or its Affiliate(s) royalties on such Distributor’s sales of Products or Processes, in which case such Distributor shall be a Sublicensee for all purposes of this Agreement.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

3

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

1.16                        “Technological Information” shall mean research data, designs, formulae, process information and other information pertaining to the invention(s) claimed in the Patent Rights which is created by Dr. Fava and Dr. Petryshen and owned by Hospital and is not confidential information of or otherwise obligated to any third party and which Dr. Fava and Dr. Petryshen knows as of the Effective Date and reasonably believes is necessary in order for Company to utilize the licenses granted hereunder, as further described in Appendix B. Company agrees to treat all Technological Information in accordance with the provisions of Appendix E.

 

2.  LICENSE

 

2.1                               Grant of License.

 

(a)                                 Subject to the terms of this Agreement and Hospital’s rights in Patent Rights, Hospital hereby grants to Company in the License Field in the License Territory:

 

(i)                                     an exclusive, royalty-bearing license under its rights in Patent Rights to make, have made, use, have used, Sell and have Sold Products and Processes;

 

(ii)                                  the right to grant sublicenses under the rights granted in Section 2.1(a)(i) to Sublicensees, provided that in each case Company shall be responsible for the performance of any obligations of Sublicensees relevant to this Agreement as if such performance were carried out by Company itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the Sublicensee directly to Hospital; and

 

(iii)                               the nonexclusive right to use Technological Information disclosed by Hospital to Company hereunder in accordance with this Agreement.

 

(b)                                 The license granted in Section 2.1(a) above includes:

 

(i)                                     the right to grant to the final purchaser, user or consumer of Products the right to use such purchased Products in a method coming within the scope of Patent Rights within the License Field and License Territory; and

 

(ii)                                  the right to grant a Distributor the right to Sell (but not to make, have made, use or have used) such Products and/or Processes for or on behalf of Company, its Affiliates and Sublicensees in a manner consistent with this Agreement.

 

(c)                                  The foregoing license grant shall include the grant of such license to any Affiliate of Company, provided that such Affiliate shall assume the same obligations as those of Company and be subject to the same terms and conditions hereunder; and further provided that Company shall be responsible for the performance of all of such obligations and for compliance with all of such terms and conditions by Affiliate. Company shall provide to Hospital a fully signed, non-redacted copy of each agreement with each Affiliate that assumes the aforesaid obligations, including all exhibits, attachments and related documents and any amendments, within thirty (30) days of request by Hospital.

 

2.2                               Sublicenses. Each sublicense granted hereunder shall be consistent with and comply with all terms of this Agreement, shall incorporate terms and conditions sufficient to enable Company to comply with this Agreement, shall prohibit any further sublicense or assignment by a Sublicensee without Hospital consent and shall provide that Hospital is a third party beneficiary thereof Any sublicense granted by Company shall be subject to the prior written approval of Hospital, which approval shall not be unreasonably withheld. Company

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

4

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

shall provide to Hospital a fully signed non-redacted copy of all sublicense agreements and amendments thereto, including all exhibits, attachments and related documents, within thirty (30) days of executing the same. Upon termination of this Agreement or any license granted hereunder for any reason, any sublicenses shall be addressed in accordance with Section 10.7. Any sublicense which is not in accordance with the forgoing provisions shall be null and void.

 

2.3                               Retained Rights; Requirements. Any and all licenses granted hereunder are subject to:

 

(a)                                 the right of Hospital and Hospital’s Affiliates and academic, government and not-for-profit institutions to make and to use the subject matter described and/or claimed in the Patent Rights; and

 

(b)                                 for Patent Rights supported by federal funding, the rights, conditions and limitations imposed by U.S. law (see 35 U.S.C. § 202 et seq. and regulations pertaining thereto), including without limitation:

 

(i)                                     the royalty-free non-exclusive license granted to the U.S. government; and

 

(ii)                                  the requirement that any Products used or sold in the United States shall be manufactured substantially in the United States.

 

2.4                               No Additional Rights. It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital other than the Patent Rights expressly licensed hereunder. Hospital shall have the right to license any Patent Rights to any other party for any purpose outside of the License Field or the License Territory.

 

2.5                               Disclosure of Technological Information. At Company’s request prior to execution of this Agreement, Hospital (through Dr. Fava or Dr. Petryshen shall use reasonable efforts to disclose in confidence within thirty (30) days after execution of this Agreement the Technological Information licensed hereunder.

 

3.  DUE DILIGENCE OBLIGATIONS

 

3.1                               Diligence Requirements. Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, best efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field. Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:

 

(a)                                 Pre-Sales Requirements.

 

1.                                      Within [* * *] of the Effective Date, Company shall raise at least $[* * *] to support development efforts of Products and Processes

2.                                      Within [* * *] of the Effective Date, Company shall [* * *];

3.                                      Within [* * *] of the Effective Date, Company shall [* * *];

4.                                      Within [* * *] of the Effective Date, Company shall [* * *];

5.                                      Within [* * *] of the Effective Date, Company shall [* * *];

6.                                      Within [* * *] of the Effective Date, Company shall [* * *]; and

7.                                      Within [* * *] of the Effective Date, Company shall [* * *].

 

(b)                                 Post-Sales Requirements.

 

(i)                                     Following the First Commercial Sale in any country in the License Territory, Company shall itself or through its Affiliates and/or Sublicensees make continuing

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Sales in such country without any elapsed time period of [* * *] or more in which such Sales do not occur.

 

(ii)                                  Company shall itself or through an Affiliate or Sublicensee make such First Commercial Sale within the following countries and regions in the License Territory within [* * *] after the Effective Date of this Agreement: [* * *].

 

Achievement of the foregoing objectives shall be deemed to satisfy Company’s obligations to use best efforts under this Section 3.1.

 

3.2                               Diligence Failures. If Hospital determines that Company has failed to fulfill any of its obligations under Section 3.1, then Hospital may treat such failure as a default and may terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4 provided, however, that Company may elect to extend any of the Diligence Requirements in accordance with Section 3.3 below.

 

3.3                               Diligence Extension. Company may elect to extend any of the Diligence Requirement in the article 3.1(a) by a maximum of [* * *] (“Diligence Extension”) upon payment to Hospital of:

(i)                                     [* * *] dollars ($[* * *]) if such an extension is for [* * *]; or;

(ii)                                  [* * *] dollars ($[* * *]) if such an extension is for [* * *];

(iii)                               [* * *] dollars ($[* * *]) if such an extension is for [* * *];

 

A Diligence Extension shall apply to the elected Diligence Requirement and all subsequent Diligence Requirements. Company may elect no more than [* * *] Diligence Extensions total and any Diligence Extension must be requested at least [* * *] prior to the date of the specific diligence Requirement for which a Diligence Extension is being requested by Company. The Diligence Extension shall take effect only if payment is made to Hospital by the date of the specific Diligence Requirement for which a Diligence Extension has been requested.

 

3.4                               Diligence Reports. Company shall provide all reports with respect to its obligations under Section 3.1 as set forth in Section 5.

 

4.  PAYMENTS AND ROYALTIES

 

4.1                               License Issue Fee. Company shall pay Hospital a non-refundable license issue fee in the amount of twenty thousand dollars ($20,000) upon execution of this Agreement.

 

4.2                               Patent Cost Reimbursement. Company shall reimburse Hospital for all costs associated with the preparation; filing, prosecution and maintenance of all Patent Rights (“Patent Costs”). As of the Effective Date, Hospital has incurred approximately thirteen thousand dollars ($13,000) in Patent Costs, which amount Company shall pay to Hospital within one year of the Effective Date. Company shall pay to Hospital, or at Hospital’s request directly to patent counsel, all other Patent Costs within [* * *] days of Company’s receipt of an invoice for such Patent Costs either from Hospital or Hospital’s patent counsel. Company agrees to indemnify, defend and hold Hospital harmless from and against any and all liabilities, damages, costs and expenses arising from the failure of Company to timely pay such invoices and Patent Costs. Hospital shall instruct patent counsel to provide copies to Hospital for hospital’s administrative files of all invoices detailing Patent Costs which are sent directly to Company. If Company pays any Patent Costs directly, Company shall advise patent counsel that Hospital is and shall remain patent counsel’s client.

 

4.3                               Annual License Fee:

 

(a)                                 Company shall pay to Hospital the following non-refundable amounts as an annual license fee within [* * *] days after each of the following anniversaries of the Effective Date:

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

6

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

(i)                                     the [* * *] anniversary of the Effective Date: [* * *] dollars ($[* * *]);

 

(ii)                                  the [* * *] anniversary of the Effective Date: [* * *] dollars ($[* * *]);

 

(iii)                               the [* * *] anniversary and on each subsequent anniversary of the Effective Date thereafter: [* * *] dollars ($[* * *]).

 

4.4                               Milestone Payments. In addition to the payments set forth in Sections 4.1 through 4.3 above, Company shall pay Hospital milestone payments as follows:

 

(a)                                 [* * *] dollars ($[* * *]) within [* * *] days of [* * *]; and

 

(b)                                 [* * *] dollars ($[* * *]) within [* * *] days of [* * *]; and

 

(c)                                  [* * *] dollars ($[* * *]) at the later of (i) [* * *]; or (ii) [* * *]; provided however that in any case this milestone payment 4.4 (c) shall be paid within [* * *] of [* * *] if it has not been paid before. For the avoidance of any doubt, this milestone 4.4 (c) shall be due in addition to any payment made under 4.4 (e) or 4.5; and

 

(d)                                 [* * *] dollars ($[* * *]) within [* * *] days of [* * *]; and

 

(e)                                  [* * *] dollars ($[* * *]) within [* * *] days of [* * *]; and

 

(f)                                   [* * *] dollars ($[* * *]) within [* * *] days of [* * *]; and

 

(g)                                  [* * *] dollars ($[* * *]) [* * *].

 

4.5                               Royalties and Sublicense Income.

 

(a)                                 Beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital:

 

(i)                                     during the term of any license granted under Section 2.1(a)(i), a royalty of [* * *] percent ([* * *]%) of the Net Sales of all Products and Processes;

 

(ii)                                  Necessary License. If Company enters into a license or otherwise acquires the use of any intellectual property on technology from a third party that is legally required to practice Patent Rights (a “Necessary License”), royalties payable to Hospital are subject to an offset of [* * *] percent ([* * *]%) of the amounts paid for royalties to such third parties under any Necessary License(s) provided however that in no event shall Company pay Hospital less than [* * *] percent ([* * *]%) of the Net Sales of all Products and Processes (“Minimum Royalty”).

 

(b)                                 Company shall pay Hospital [* * *] percent ([* * *]%) of any and all Sublicense Income before [* * *].

 

(c)                                  Company shall pay Hospital [* * *] percent ([* * *]%) of any and all Sublicense Income after [* * *].

 

(d)                                 All payments due to Hospital under this Section 4.5 shall be due and payable by Company within [* * *] days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.3 and 5.4.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

7

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

4.6                               Form of Payment. All payments due under this Agreement shall be drawn on a United States bank and shall be payable in United States dollars. Each payment shall reference this Agreement and its Agreement Number and identify the obligation under this Agreement that the payment satisfies. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States, as reported in The Wall Street Journal, on the last working day of the applicable Reporting Period. Such payments shall be without deduction of exchange, collection or other charges, and, specifically, without deduction of withholding or similar takes or other government imposed fees or taxes, except as permitted in the definition of Net Sales.

 

Checks for all payments due to the Hospital under this Agreement shall be made payable to the Hospital and addressed as set forth below:

 

Massachusetts General Hospital

BOA-Lockbox Services

PCSR Lockbox 11415007

MA5-527-02-07

2 Morrissey Blvd

Dorchester, MA 02125

Reference Agreement #: A221771

 

Payments via wire transfer should be made as follows:

 

ACH Credit: [* * *]

Federal Reserve Wire: [* * *]

SWIFT Code: [* * *]

Account [* * *]

Massachusetts General Hospital

Bank of America

100 Federal Street

Boston, MA 02110

Reference Agreement #: [* * *]

 

4.7                               Overdue Payments. The payments due under this Agreement shall, if overdue, bear interest beginning on the first day following the Reporting Period to which such payment was incurred and until payment thereof at a per annum rate equal to [* * *], such interest rate being compounded on the last day of each Reporting Period, not to exceed the maximum permitted by law. Any such overdue payments when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not preclude Hospital from exercising any other rights it may have as a consequence of the lateness of any payment.

 

5.  REPORTS AND RECORDS

 

5.1                               Diligence Reports. Within [* * *] days after the end of each calendar year, Company shall report in writing to Hospital on progress made toward the objectives set forth in Section 3.1 during such preceding 12 month period, including, without limitation, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing and the number of sublicenses entered into and marketing.

 

5.2                               Milestone Achievement Notification. Company shall report to Hospital the dates on which it achieves the milestones set forth in Section 4.4 within [* * *] days of each such occurrence.

 

5.3                               Sales Reports. Company shall report to Hospital the date of the First Commercial Sale in each country of the License Territory within [* * *] days of each such occurrence. Following the First Commercial Sale, Company shall deliver reports to Hospital within [* * *] days after the end of each Reporting Period. Each

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

8

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

report under this Section 5.4 shall have substantially the format outlined in Appendix C, shall be certified as correct by an officer of Company and shall contain at least the following information as may be pertinent to a royalty accounting hereunder for the immediately preceding Reporting Period:

 

(a)                                 the number of Products and Processes Sold by Company, its Affiliates and Sublicensees in each country;

 

(b)                                 the amounts billed, invoiced and received by Company, its Affiliates and Sublicensees for each Product and Process, in each country, and total billings or payments due or made for all Products and Processes;

 

(c)                                  calculation of Net Sales for the applicable Reporting Period in each country, including an itemized listing of permitted offsets and deductions;

 

(d)                                 total royalties payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and

 

(e)                                  any other payments due to Hospital under this Agreement.

 

If no amounts are due to Hospital for any Reporting Period, the report shall so state.

 

5.4                               Sublicense Income Reports. Company shall, along with delivering payment as set forth in Section 4.6, report to Hospital within [* * *] days of receipt the amount of all Sublicense Income received by Company, and Company’s calculation of the amount due and paid to Hospital from such income, including an itemized listing of the source of income comprising such consideration, and the name and address of each entity making such payments in substantially the format outlined in Appendix D.

 

5.5                               Audit Rights. Company shall maintain, and shall cause each of its Affiliates and Sublicensees to maintain, complete and accurate records relating to the rights and obligations under this Agreement and any amounts payable to Hospital in relation to this Agreement, which records shall contain sufficient information to permit Hospital and its representatives to confirm the accuracy of any payments and reports delivered to Hospital and compliance in all other respects with this Agreement. Company shall retain and make available, and shall cause each of its Affiliates and Sublicensees to retain and make available, such records for at least [* * *] years following the end of the calendar year to which they pertain, to Hospital and/or its representatives and upon at least [* * *] days’ advance written notice, for inspection during normal business hours, to verify any reports and payments made and/or compliance in other respects under this Agreement. If any examination conducted by Hospital or its representatives pursuant to the provisions of this Section show an underreporting or underpayment of [* * *] percent ([* * *]%) or more in any payment due to Hospital hereunder, Company shall bear the full cost of such audit and shall remit any amounts due to Hospital (including interest due in accordance with Section 4.7) within [* * *] days of receiving notice thereof from Hospital.

 

6.  PATENT PROSECUTION AND MAINTENANCE

 

6.1                               Prosecution. Hospital shall be responsible for the preparation, filing, prosecution and maintenance of all patent applications and patents included in Patent Rights. Company shall reimburse Hospital for Patent Costs incurred by Hospital relating thereto in accordance with Section 4.2.

 

6.2                               Copies of Documents. With respect to any Patent Right licensed hereunder, Hospital shall instruct the patent counsel prosecuting such Patent Right to (i) copy Company on patent prosecution documents that are received from or filed with the United States Patent and Trademark Office and foreign equivalent, as applicable; (ii) if requested by Company, provide Company with copies of draft submissions to the USPTO prior to filing; and (iii) give consideration to the comments and requests of Company or its patent counsel.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

9

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

6.3                               Company’s Election Not to Proceed. Company may elect to surrender any patent or patent application in Patent Rights in any country upon [* * *] days advance written notice to Hospital. Such notice shall relieve Company from the obligation to pay for future Patent Costs but shall not relieve Company from responsibility to pay Patent Costs incurred prior to the expiration of the [* * *] day notice period. Such U.S. or foreign patent application or patent shall thereupon cease to be a Patent Right hereunder, Company shall have no further rights therein and Hospital shall be free to license its rights to that particular U.S. or foreign patent application or patent to any other party on any terms.

 

6.4                               Confidentiality of Prosecution and Maintenance Information. Company agrees to treat all information related to prosecution and maintenance of Patent Rights as Confidential Information in accordance with the provisions of Appendix E.

 

7.  THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

 

7.1                               Hospital Right to Prosecute. Hospital will protect its Patent Rights from infringement and prosecute infringers when, in its sole judgment, such action may be reasonably necessary, proper and justified. If Company shall have supplied Hospital with written evidence demonstrating to Hospital’s reasonable satisfaction prima facie infringement of a claim of a Patent Right in the License Field in the License Territory by a third party which poses a material threat to Company’s rights under this Agreement, Company may by notice request Hospital to take steps to protect such Patent Right. Hospital shall notify Company within [* * *] of the receipt of such notice whether Hospital intends to prosecute the alleged infringement. If Hospital notifies Company that it intends to so prosecute, Hospital shall, within [* * *] months of its notice to Company either (i) cause such infringement to terminate, or (ii) initiate legal proceedings against the infringer.

 

7.2                               Company Right to Prosecute. In the event Hospital notifies Company that Hospital does not intend to prosecute infringement identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s expense with respect to a claim of a Patent Right in the License Field in the License Territory. Before commencing such action, Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the advisability of bringing suit, the selection of counsel and the jurisdiction for such action (provided Company must have Hospital’s prior written consent with respect to selection of jurisdiction for any action in which Hospital may be joined as a party-plaintiff) and shall use reasonable efforts to accommodate the views of Hospital regarding the proposed action, including without limitation with respect to potential effects on the public interest. Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital harmless therefrom, regardless of whether Hospital is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance with Section 7.5 below.

 

7.3                               Hospital Joined as Party-Plaintiff. If Company elects to commence an action as described in Section 7.2 above, Hospital shall have, in its sole discretion, the option to join such action as a party-plaintiff. If Hospital is required by law to join such action as a party-plaintiff, Hospital may either, in its sole discretion, permit itself to be joined as a party-plaintiff at the sole expense of Company, or assign to Company all of Hospital’s right, title and interest in and to the Patent Right which is the subject of such action (subject to all of Hospital’s obligations to the government under law and any other rights that others may have in such Patent Right). If Hospital makes such an assignment, such action by Company shall thereafter be brought or continued without Hospital as a party; provided, however, that Hospital shall continue to have all rights of prosecution and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as if the assigned Patent Right were still licensed to Company hereunder.

 

7.4                               Notice of Actions; Settlement. Company shall promptly inform Hospital of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

10

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

of any action relating to Patent Rights, including but not limited to appeals, without the prior written consent of Hospital.

 

7.5                               Cooperation. Each Party agrees to cooperate reasonably in any action under Section 7 which is controlled by the other Party, provided that the controlling party reimburses the cooperating party for any costs and expenses incurred by the cooperating party in connection with providing such assistance, except for the expense of any independent counsel retained by the cooperating party in accordance with this Section 7.5. Such controlling party shall keep the cooperating party informed of the progress of such proceedings and shall make its counsel available to the cooperating party. The cooperating party shall also be entitled to independent counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing suit in accordance with Section 7.6.

 

7.6                               Recovery. Any award paid by third parties as the result of such proceedings (whether by way of settlement or otherwise) shall first be applied to reimbursement of any legal fees and expenses incurred by either Party and then the remainder shall be divided between the Parties as follows:

 

(a)                                 (i)                                     Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the court shall have applied; and

 

(ii)                                  Hospital shall receive an amount equal to the royalties and other amounts that Company would have paid to Hospital if Company had Sold the infringing Products and Services rather than the in flinger; and

 

(b)                                 the balance, if any, remaining after Company and Hospital have been compensated under Section 7,6(a) shall be shall be shared equally by the Parties.

 

8.  INDEMNIFICATION AND INSURANCE

 

8.1                               Indemnification.

 

(a)                                 Company shall indemnify, defend and hold harmless Hospital and its Affiliates and their respective trustees, directors, officers, medical and professional staff, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process or service made, used, or sold or performed pursuant to any right or license granted under this Agreement.

 

(b)                                 Company agrees, at its own expense, to provide attorneys reasonably acceptable to the Hospital to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought; provided, however, that any Indemnitee shall have the right to retain its own counsel, at the expense of Company, if representation of such Indemnitee by counsel retained by Company would be inappropriate because of conflict of interests of such Indemnitee and any other party represented by such counsel. Company agrees to keep Hospital informed of the progress in the defense and disposition of such claim and to consult with Hospital prior to any proposed settlement.

 

(c)                                  This section 8.1 shall survive expiration or termination of this Agreement.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

11

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

8.2                               Insurance.

 

(a)                                 Beginning at such time as any such product, process or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Company, an Affiliate or Sublicensee, Company shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $[* * *] per incident and $[* * *] annual aggregate and naming the indemnitees as additional insureds. Such commercial general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for Company’s indemnification under Section 8.1 of this Agreement. If Company elects to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of $[* * *] annual aggregate) such self-insurance program must be acceptable to the Hospital and the Risk Management Foundation. The minimum amounts of insurance coverage required under this Section 8.2 shall not be construed to create a limit of Company’s liability with respect to its indemnification under Section 8,1 of this Agreement.

 

(b)                                 Company shall provide Hospital with written evidence of such insurance upon request of Hospital. Company shall provide Hospital with written notice at least [* * *] days prior to the cancellation, non-renewal or material change in such insurance; if Company does not obtain replacement insurance providing comparable coverage prior to the expiration of such [* * *] day period, Hospital shall have the right to terminate this Agreement effective at the end of such [* * *] day period without notice or any additional waiting periods.

 

(c)                                  Company shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any such product, process, or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Company or by a licensee, affiliate or agent of Company and (ii) a reasonable period after the period referred to in (c) (i) above which in no event shall be less than [* * *] years.

 

(d)                                 This section 8.2 shall survive expiration or termination of this Agreement.

 

9.  DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY

 

9.1                               Title to Patent Rights. To the best knowledge of Hospital’s Office of Innovation, Hospital is the owner by assignment from Dr.Fava and Dr.Petryshen of the Patent Rights and has the authority to enter into this Agreement and license the Patent Rights to Company hereunder.

 

9.2                               No Warranties. HOSPITAL MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME. SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, HOSPITAL MAKES NO WARRANTY OR REPRESENTATION (i) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF HOSPITAL OR OF ANY THIRD PARTY.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

12

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

9.3                               Limitation of Liability. IN NO EVENT SHALL ‘HOSPITAL OR ANY OF ITS AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL OR PROFESSIONAL STAFF, EMPLOYEES AND AGENTS BE LIABLE TO LICENSEE OR ANY OF ITS AFFILIATES, SUBLICENSEES OR DISTRIBUTORS FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE OR RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT LIMITATION ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER HOSPITAL SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.

 

10.  TERM AND TERMINATION

 

10.1                        Term. The term of this Agreement shall commence on the Effective Date and shall remain in effect the date on which all issued patents and filed patent applications within the Patent Rights have expired or been abandoned unless this Agreement is terminated earlier in accordance with any of the other provisions of Section 10.

 

10.2                        Termination for Failure to Pay. If Company fails to make any payment due hereunder, Hospital shall have the right to terminate this Agreement upon [* * *] business days written notice, unless Company makes such payments plus any interest due, as set forth in Section 4.7, within said [* * *] day notice period. If payments are not made, Hospital may immediately terminate this Agreement at the end of said [* * *] day period. Company shall be entitled to only [* * *] such cure periods in a calendar year; for a [* * *] failure to make payment on time, Hospital shall have the right to terminate this Agreement immediately upon written notice.

 

10.3                        Termination for Insurance and Insolvency.

 

(a)                                 Insurance. Hospital shall have the right to terminate this Agreement in accordance with Section 8.2(b) if Company fails to maintain the insurance required by Section 8.2.

 

(b)                                 Insolvency and other Bankruptcy Related Events. Hospital shall have the right to terminate this Agreement immediately upon written notice to Company with no further notice obligation or opportunity to cure if Company: (i) shall become insolvent; (ii) shall make an assignment for the benefit of creditors; or (iii) or shall have a petition in bankruptcy filed for or against it.

 

10.4                        Termination for Non-Financial Default. If Company, any of its Affiliates or any Sublicensee shall default in the performance of any of its other obligations under this Agreement not otherwise covered by the provisions of Section 10.2 and 10.3, and if such default has not been cured within [* * *] days after notice by Hospital in writing of such default, Hospital may immediately terminate this Agreement, and/or any license granted hereunder with respect to the country or countries in which such default has occurred, at the end of said [* * *] day cure period. Hospital shall also have the right to terminate this Agreement and/or any such license immediately, upon written notice, in the event of repeated defaults even if cured within such [* * *] day periods.

 

10.5                        Challenging Validity. During the term of this Agreement, Company shall not challenge, and shall restrict Company Affiliates and Sublicensees from challenging, the validity of the Patent Rights and in the event of any breach of this provision Hospital shall have the right to terminate this Agreement and any license granted hereunder immediately. In addition, if the Patent Rights are upheld Company shall reimburse Hospital for its legal costs and expenses incurred in defending any such challenge.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

13

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

10.6                        Termination by Company. Company shall have the right to terminate this Agreement by giving sixty (60) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9.

 

10.7                        Effect of Termination on Sublicenses. Any sublicenses granted by Company under this Agreement shall provide for termination or assignment to Hospital of Company’s interest therein, at the option of Hospital, upon termination of this Agreement or upon termination of any license hereunder under which such sublicense has been granted.

 

10.8                        Effects of Termination of Agreement. Upon termination of this Agreement or any of the licenses hereunder for any reason, final reports in accordance with Section 5 shall be submitted to Hospital and all royalties and other payments, including without limitation-any unreimbursed Patent Costs, accrued or due to Hospital as of the termination date shall become immediately payable. Company shall cease, and shall cause its Affiliates and Sublicensees to cease under any sublicense granted by Company, all Sales and uses of Products and Processes upon such termination, subject to Section 10.9. The termination or expiration of this Agreement or any license granted hereunder shall not relieve Company, its Affiliates or Sublicensees of obligations arising before such termination or expiration.

 

10.9                        Inventory. Upon early termination of this Agreement other than for Company default, Company, Company Affiliates and Sublicensees may complete and sell any work-in-progress and inventory of Products that exist as of the effective date of termination provided that (i) Company pays Hospital the applicable running royalty or other amounts due on such Net Sales in accordance with the terms and conditions of this Agreement, and (ii) Company, Company Affiliates and Sublicensees shall complete and sell all Work-in-progress and inventory of Products within [* * *] after the effective date of termination. Upon expiration of this Agreement, Company shall pay to Hospital the royalties set forth in Section 4.5(a) for Sales of any Product that was in inventory or was a work-in-progress on the date of expiration of the Agreement.

 

11.  COMPLIANCE WITH LAW

 

11.1                        Compliance. Company shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees comply with, all government statutes and regulations that relate to Products and Processes, including, but not limited to, those of the Food and Drug Administration and the Export Administration, as amended, and any applicable laws and regulations of any other country in the License Territory. Company agrees that it shall be solely responsible for obtaining any necessary licenses to export, re-export, or import Products or Processes covered by Patent Rights and/or Confidential Information. Company shall indemnify and hold harmless Hospital for any breach of Company’s obligations under this Section 11.1.

 

11.2                        Patent Numbers. Company shall cause all Products sold in the United States to be marked with all applicable U.S. Patent Numbers, to the full extent required by United States law. Company shall similarly cause all Products shipped to or sold in any other country to be marked in such a manner as to conform with the patent laws and practices of such country.

 

12.  MISCELLANEOUS

 

12.1                        Entire Agreement. This Agreement constitutes the entire understanding between the Parties with respect to the subject matter hereof.

 

12.2                        Notices. Any notices, reports, waivers, correspondences or other communications required under or pertaining to this Agreement shall be in writing and shall be delivered by hand, or sent by a reputable overnight mail service (e.g.; Federal Express), or by first class mail (certified or registered), or by facsimile confirmed by one of the foregoing methods, to the other party. Notices will be deemed effective (a) three (3) working days after deposit, postage prepaid, if mailed, (b) the next day if sent by overnight mail, or (c) the

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

14

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

same day if sent by facsimile and confirmed as set forth above or delivered by hand. Unless changed in writing in accordance with this Section, the notice address for Hospital shall be as follows:

 

Executive Director, Partners Innovation

Massachusetts General Hospital

101 Huntington Avenue, 4th Floor

Boston, MA 02199

 

Fax No. (617) 954-9361

 

the notice address for Company shall be as follows:

Biohaven Pharmaceutical Holding Company LTD

Suite 304

234 Church Street

New Haven, CT 06510

Signatory: Robert Berman, M.D. (Title: Chief Medical Officer)

Fax: 203-244-4239

 

12.3                        Amendment; Waiver. This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by an authorized signatory of the Parties or, in the case of a waiver, by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a further or continuing waiver of such condition or term or of any other condition or term.

 

12.4                        Binding Effect. This Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

 

12.5                        Assignment. Company shall not assign this Agreement or any of its rights or obligations under this Agreement without the prior written consent of Hospital; provided, however, that if Company has fulfilled its diligence obligations as set forth in Section 3, no such consent will be required to assign this Agreement to a successor of the Company’s business to which this Agreement pertains or to a purchaser of substantially all of the Company’s assets related to this Agreement, so long as such successor or purchaser shall agree in writing to be bound by all of the terms and conditions hereof prior to such assignment. Company shall notify Hospital in writing of any such assignment and provide a copy of all assignment documents and related agreements to Hospital within thirty (30) days of such assignment. Failure of an assignee to agree to be bound by the terms hereof or failure of Company to notify hospital and provide copies of assignment documentation shall be grounds for termination of this Agreement for default. Further, neither any rights granted under this Agreement nor any sublicense may be assigned by any Sublicensee without the prior written consent of Hospital.

 

12.6                        Force Majeure. Neither Party shall be responsible for delays resulting from causes beyond the reasonable control of such Party, including without limitation fire, explosion, flood, war, sabotage, strike or riot, provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

12.7                        Use of Name. Neither Party shall use the name of the other Party or of any trustee, director, officer, staff member, employee, student or agent of the other Party or any adaptation thereof in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the Party or individual whose name is to be used. For Hospital, such approval shall be obtained from Hospital’s VP of Public Affairs.

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

15

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

12.8                        Governing Law. This Agreement shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth of Massachusetts, excluding with respect to conflict of laws, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted. Each Party agrees to submit to the exclusive jurisdiction of the Superior Court for Suffolk County, Massachusetts, and the United States District Court for the District of Massachusetts with respect to any claim, suit or action in law or equity arising in any way out of this Agreement or the subject matter hereof.

 

12.9                        Hospital Policies. Company acknowledges that Hospital’s employees and medical and professional staff members and the employees and staff members of Hospital’s Affiliates are subject to the applicable policies of Hospital and such Affiliates, including, without limitation, policies regarding conflicts of interest, intellectual property and other matters. Company shall provide Hospital with any agreement it proposes to enter into with any employee or staff member of Hospital or any of Hospital’s Affiliates for Hospital’s prior review and shall not enter into any oral or written agreement with such employee or staff member which conflicts with any such policy. Hospital shall provide Company, at Company’s request, with copies of any such policies applicable to any such employee or staff member.

 

12.10                 Severability. If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the parties that the remainder of this Agreement shall not be effected thereby. It is further the intention of the parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the parties to such invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.

 

12.11                 Survival. In addition to any specific survival references in this Agreement, Sections 1, 2.4, 4.2, 4.6, 4.7, 5.3, 54, 5.5, 6.4, 8.1, 8.2, 9.2, 9.3, 10.7, 10.8, 10.9, 12.1, 12.2, 12.3, 12.4, 12.7, 12.8, 12.9, 12.10, 12.11, 12.12 and 12.13 shall survive termination or expiration of this Agreement. Any other rights, responsibilities, obligations, covenants and warranties which by their nature should survive this Agreement shall similarly survive and remain in effect.

 

12.12                 Interpretation. The parties hereto are sophisticated, have had the, opportunity to consult legal counsel with respect to this transaction and hereby waive any presumptions of any statutory or common law rule relating to the interpretation of contracts against the drafter.

 

12.13                 Headings. All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

 

[Remainder of page intentionally left blank]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

16

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

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

 

	
BIOHAVEN PHARMACEUTICAL HOLDING   COMPANY LTD.
    	
THE GENERAL HOSPITAL   CORPORATION
    
	
 
    	
 
    
	
 
    	
 
    
	
By: 
    	
 
    	
/s/ Rob Berman
    	
 
    	
By: 
    	
/s/ Kim Betres
    
	
 
    	
 
    	
Name:  Rob Berman
    	
 
    	
 
    	
Name:    Kim Betres
    
	
 
    	
 
    	
 
    	
 
    
	
Title: 
    	
CMO
    	
 
    	
Title:
    	
 Associate Director, Research &   Licensing
    
	
 
    	
 
    	
 
    	
 
    
	
Date: 
    	
20-Sep-2014
    	
 
    	
Date: 
    	
Sept 22 2014
    

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

17

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix A

 

DESCRIPTION OF PATENT RIGHTS

 

[* * *]

 

TO BE INCLUDED BY-AMENDMENT

 

[* * *]

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

18

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix B

 

DESCRIPTION OF TECHNOLOGICAL INFORMATION

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

19

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix C

SALES REPORTS

 

	
AGREEMENT INCOME REPORT
    	
Royalty   Income
    
	
[MGH][BWH] Agreement #-
    
	
Licensee -
    

Sub-Licensee -

 

Separate reports must be filed for:

1.                                      Each Product sold.

2.                                      Each country of sale, if different deductions or royalty rates apply.

 

Product Name:

Report Time Period:

 

From                   mm/dd/yyyy

To                                 mm/dd/yyyy

 

 

	
Country of Sale
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Quantity Sold
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Gross Sales (USD)
    	
 
    	
$
    	
 
    	
 
    	
$
    	
 
    	
 
    	
$
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Exchange Rate
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
											

 

Deductions (itemize)

 

Please list each deduction separately. Use same definition as appears in Agreement and include the contract paragraph as a reference (Std Section 1.17(a)(ii) line item deductions listed below).

 

	
A1.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
A2.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
A3.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
A4.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
B.
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Total Deductions
    	
 
    	
(     
    	
)
    	
(     
    	
)
    	
(     
    	
)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Net Sales
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Royalty Percentage
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Credits (itemize)
    	
 
    	
(     
    	
)
    	
(     
    	
)
    	
(     
    	
)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Royalties Due
    	
 
    	
$
    	
 
    	
 
    	
$
    	
 
    	
 
    	
$
    	
 
    	
 
    
											

 

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

20

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

PLEASE ATTACH DETAIL SALES REPORTS AS REQUIRED

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

21

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(B)(4) and 230.406

 

Appendix D

 

	
AGREEMENT INCOME REPORT
    	
Sublicense   Income
    
	
[MGH][BWH] Agreement #-
    	
 
    
	
Licensee -
    	
 
    

Sub-Licensee -

 

Separate reports must be filed for Payments associated with each Product:

 

Product Name:

 

Report Time Period:

 

From      mm/dd/yyyy

To           mm/dd/yyyy

 

 

 

Detailed Explanation of Payment 
 Required for “Other Payment”

 

	
Annual Fees/Minimum Royalties
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Milestone Payments
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Sublicense Fees and Royalties
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Other Payment
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Other Payment
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Other Payment
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
TOTAL
    	
 
    	
$
    	
 
    	
 
    	
 
    	
 
    

 

 

 

PLEASE ATTACH DETAIL AS REQUIRED

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

22

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00269-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00269-of-00352.parquet"}]]