Document:

Exhibit 10.4

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

YM477 LICENSE AGREEMENT

 

This Agreement is made as of August 15, 2005, by and between Astellas Pharma Inc., a company organized and existing under the laws of Japan and having its principal office at 3·11, Nihonbasbi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (“Licensor”) and AkaRx Corp., a company organized and existing under the laws of Delaware and having its principal office at Mack Centre IV, 4th Floor, 61 S. Paramus Road, Paramus, NJ 07652 (“Licensee”).

 

RECITALS

 

A.            Licensor has invented and developed the Compound (as defined below).

 

B.            Licensor owns the Licensor Patents and the Licensor Know-How (each as defined below).

 

C.            Licensee desires to obtain the license to develop and commercialize the Compound and the Product in the Territory (as defined below) and Licensor is willing to grant such a license to Licensee under the terms and conditions as set forth below.

 

D.            Robert Desjardins, Rudy Lucek, Steven Silbert, Donna Tempel and David Laveman, Licensor and Licensee entered into a certain Memorandum Of Understanding dated as of December 8, 2004, pertaining to the Compound, among other things (the “MOU”).

 

E.            Licensor changed its name from Yarnanouchi Pharmaceutical Co., Ltd. to Astellas Pharma Inc.

 

NOW THEREFORE, in consideration of the premises and the mutual agreements hereinafter contained, the Parties hereto agree as follows:

 

1. DEFINITIONS

 

In this Agreement, the following terms when capitalized shall have the respective meanings set forth below and the singular shall include the plural and vice versa.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

1

 

“Affiliate” shall mean any Person controlling, controlled by or under common control with the Person as to which such status is in question. For purposes of this definition, the term “control” means direct or indirect ownership of more than fifty percent (50%) of the voting stock or other voting interest of a Person or the possession of the power to direct the management and policies of a Person.

 

“Business Day” shall mean a day on which commercial banks in New York City, New York, United States of America are open for business.

 

“Calendar Quarter” shall mean, for each Calendar Year, each of the three month periods ending on March 31, June 30, September 30 and December 31; provided, however, that the first Calendar Quarter for the first Calendar Year shall extend from the Effective Date to the end of the next calendar quarter following the calendar quarter in which the Effective Date occurs.

 

“Calendar Year” shall mean, for the first Calendar Year, the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and each successive period beginning on January l and ending twelve (12) consecutive calendar months later on December 31.

 

“cGMP” shall mean the applicable then-current Good Manufacturing Practices guidelines and regulations, respectively, of the US Food and Drug Administration, or their equivalent outside the United States.

 

“cGMP Compound” shall have the meaning set forth in Section 10.01.

 

“Compound” shall mean [***] together with all other compounds covered by the Licensor Patents.

 

“Condition Precedent” shall have the meaning set forth in Section 2.01.

 

‘‘Confidential Information” shall mean all information, data, technology and know-how disclosed by one Party to the other Party for the purposes of this Agreement whether orally, electronically, visually or in writing which (a) is marked “confidential” or with any similar marking or legend or is otherwise identified as confidential, (b) if orally, electronically or visually disclosed is further reduced to summary written  form

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

2

 

describing such information, data, technology and know-how and is delivered to  the receiving  Party within thirty (30) days after disclosure, referencing the place and date of such oral, visual, electronic or written disclosure and the names of the persons to whom such disclosure was made, or (c) is “Confidential Information” provided under the MOU.

 

“Control” or “Controlled” shall mean the legal authority or right of a Party to grant a license or sublicense of intellectual property rights to another Party.

 

“Date Of Launch” shall mean, with respect to a particular country in the Territory, the date on which Licensee or its Affiliate or sublicensee first sells or distributes the Product for its intended use to a Third Party following Regulatory Approval to engage in commercial sales in such country.

 

“EEA” shall mean the European Economic Area, currently comprising the 25 Member States of the European Union, as well as Norway, Iceland and Liechtenstein, as the same is constituted from time to time.

 

“Effective Date” shall mean the date on which the Condition Precedent is satisfied in

accordance with Section 2.01.

 

“Knowledge of Licensor” shall mean the knowledge of the employees of Licensor holding managerial position in its intellectual property department, only to the extent that such knowledge is actually known to them.

 

“Licensor Information” shall mean Licensor Know-How and any and all information, data, technology, documents and other materials related to the Compound and/or the Product owned or Controlled by Licensor as of the Effective Date and which is needed by or useful to Licensee in order for Licensee to perform its obligations or to exploit its rights under this Agreement.

 

“Licensor Know-How” shall mean any and all scientific, medical, technical and/or regulatory information relating to the Compound and/or the Product which is in the possession of or available to Licensor or any of its Affiliate as of the Effective Date and which is needed by or useful to Licensee in order for Licensee to perform its obligations or to exploit its rights under this Agreement.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

3

 

“Licensor Patent(s)” shall mean the patent applications or patents identified in Appendix A attached hereto, as well as any patents granted thereon, continuations, continuations-in-part, continued prosecution applications, substitutes, divisions, reissues, revisions, re-examinations, registrations, renewals, extensions, patents of addition, supplemental protection certificates, revivals and foreign counterparts of the foregoing.

 

“Licensor Material” shall mean reference standard for the Compound and reference material for Compound impurities.

 

“NDA” shall mean any application seeking Regulatory Approval.

 

“Net Sales” shall mean, for any period, the gross amounts invoiced for sales of the Product by Licensee, its Affiliates and sublicensees (or any of them), to Third Parties (but not including sales relating to transactions between Licensee, its Affiliates and their respective sublicensees), less the total of the following deductions which shall be directly related to such sale of the Product:

 

(a)                                 direct or indirect credits and allowances or adjustments (consistent with United States generally accepted accounting principles, to the extent applicable) granted to such customers on account of price adjustments, government or other rebates (e.g. Medicare, Medicaid, pharmacy, insurance carrier, hospital or health maintenance organization rebates), whether or not in connection with promotion or formulary inclusion, rejections, rejections or returns in respect of the Product previously sold;

 

(b)                                 any trade, volume and cash discounts (including any discounts for prompt payment), rebates, indigent patient programs and charge-backs granted to customers where there are direct shipments by Licensee, its Affiliates and/or its sublicensee to such customers, and management fees paid during the relevant time period to group purchasing organizations; and

 

(c)                                  any sales or other like taxes imposed upon the sale of the Product to the extent included in the gross sales price (e.g. Value Added Tax);

 

(d)                                 any freight, postage and transit insurance costs;

 

and

 

(e)                                  any other specifically identifiable amounts included in Product gross invoice amount that should be credited for reasons substantially similar to those set forth above.

 

provided that the sum of (d) and (e) shall be no more than [***] percent ([***]%) of the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

4

 

gross amounts invoiced for sales of the Product.

 

“Non-cGMP Compound’, shall have the meaning set forth in Section 10.01.

 

“Party” shall mean Licensor or Licensee; “Parties” shall mean Licensor and Licensee.

 

“Person’’ shall mean any natural person or persons, corporation, limited liability company, general partnership, limited partnership, joint venture, proprietorship or other business organization.

 

“Phase I Study” shall mean any study in healthy humans to obtain initial data regarding the safety and pharmacokinetics of a product

 

“Phase II Study” shall mean any study in humans of the safety, dose range and efficacy of a product which is conducted after Phase I Studies of such product have been complete and are usually intended to allow selection of doses for the conduct of a Phase III Study.

 

“Phase III Study” shall mean any controlled study in humans of the efficacy and safety of a product which is conducted after Phase II Study has been completed and which is prospectively designed to demonstrate statistically whether the product is safe and effective for use in a particular indication and is usually intended to be sufficient to support registration of the Product.

 

“Product” shall mean any product containing the Compound, in any dosage form, as a sole active ingredient or in any combination with other active ingredients, for all uses.

 

“Regulatory Approval” shall mean any and all approvals (including any applicable supplements, amendments, pre- and post-approvals, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity), licenses, registrations, or authorizations of any Regulatory Authority necessary for the manufacture, distribution, use, storage, import, export, transport, promotion, marketing and sale of the Compound or the Product in a country or jurisdiction.

 

“Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau, commission, council, court, tribunal, arbitrator, official or other instrumentality of a governmental entity in any country in the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

5

 

Territory.

 

“Scientific Knowledge of Licensor” shall mean the knowledge of the employees of Licensor holding managerial position in its drug discovery research laboratory, only to the extent that such knowledge is actually known to them.

 

“Specifications” shall mean the specification of cGMP Compound decided by Licensor and delivered to Licensee in writing.

 

“Territory” shall mean the world.

 

“Third Party” shall mean any Person, other than a Party or any of its Affiliates.

 

2. CONDITION PRECEDENT

 

2.01                        It is a condition precedent for this Agreement becoming effective that Licensee receives from an initial equity financing transaction or series of such transactions net proceeds equal to or exceeding five million U.S. dollars ($5,000,000) on or before September 30, 2005 (the “Condition Precedent”). In the event that the Condition Precedent is not fulfilled by such date, this Agreement will become null and void immediately without penalty to either party.

 

3. LICENSE

 

3.01                        Licensor hereby grants to Licensee, and Licensee hereby accepts, an exclusive license, with the right to sublicense through multiple tiers, to make, have made, use, have used, develop, register, import, market, promote, distribute, offer to sell, sell, have sold and otherwise exploit in all regards the Compound and the Product in Territory under Licensor Patents and Licensor Information.

 

4. DEVELOPMENT

 

4.01                        Licensee shall use commercially reasonable efforts to conduct, at its own cost, any pre-clinical and clinical development activities for the Product that are necessary to seek Regulatory Approval of the Product in those jurisdictions

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

6

 

chosen by Licensee in the exercise of its reasonable business judgment, provided that such jurisdictions shall at least include the United States and EEA.

 

4.02                        All results, data, information, know-how and technology obtained in the course of such development activities with respect to the Product conducted by Licensee or any of its Affiliates or sublicensees shall be solely owned by Licensee or such Affiliate or sublicensees.

 

4.03                        To the extent necessary to meet applicable regulatory requirements, Licensor shall be responsible for preserving all types of raw data that are obtained in the course of all activities, studies and research in connection with the Compound and the Product.  Licensor shall allow Licensee or any Regulatory Authority to audit on and have full access to, at any reasonable times and places, such raw data to the extent necessary or required for any Regulatory Approval in the Territory.

 

5. REGISTRATION

 

5.01                        Licensee shall, as soon as practicable after the completion of the development activities set forth in Article 4, file an NDA in the name of Licensee or any of its Affiliates or sublicensees with Regulatory Authorities in those relevant jurisdictions chosen by Licensee in the exercise of its reasonable business judgment pursuant to Section 4.01 and shall use commercially reasonable efforts to obtain Regulatory Approvals in such jurisdictions.

 

5.02                        Licensee shall be responsible for all regulatory matters (including communications with regulatory authorities) concerning the Compound and the Product. All regulatory filings pertaining to the clinical development and approval for sale of Product shall be in the name of, and owned by, Licensee.

 

6. RECALL

 

6.01                        Licensee shall have the right to determine whether and upon what terms and conditions to recall the Product in any country in Territory. Licensee and its Affiliates shall be responsible for discussions with Regulatory Authorities regarding all aspects of a recall decision and the execution thereof. Any costs or expenses of any recall shall be borne by Licensee and Licensee shall reimburse

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

7

 

Licensor for any costs or expenses reasonably incurred by Licensor in connection with the same, if any, provided however, if such recall is caused partially or solely by (i) any material breach of this Agreement by Licensor, (ii) any gross negligence, willful misconduct or violation of applicable law by Licensor or any of its Affiliates, or(iii) failure of the cGMP Compound supplied by Licensor or any of its Affiliates to meet the Specifications or applicable cGMPs or other applicable law, rule or regulation, then Licensor shall bear the costs and expenses of any recall under this Section to the extent such recall has resulted therefrom.

 

7. INFORMATION

 

7.01                        Licensor shall provide, and shall cause its Affiliates to provide, Licensee with all Licensor Information. Licensee shall have the right to provide such Licensor Information to any of its Affiliates and sublicensees for the purpose of the development, registration and commercialization of the Product.

 

7.02                        Licensee shall timely but at least semi-annually inform Licensor of its progress of any pre-clinical and clinical development activities for the Product.

 

8. PAYMENTS

 

8.01                        In consideration for the rights granted under this Agreement by Licensor, Licensee shall make one-time non-refundable and non-creditable payments to Licensor in respect of the Product within thirty (30) days after the first occurrence of each of the corresponding events listed below, in the amount provided:

 

	
 
    	
 
    	
Milestone Event
    	
 
    	
Milestone Payment Amount
    
	
(a)
    	
 
    	
The Condition Precedent is satisfied in accordance   with Section 2.01.
    	
 
    	
Two hundred and fifty   thousand U.S. Dollars ($250,000)
    
	
(b)
    	
 
    	
Initiation of Phase I Study in the United States
    	
 
    	
Two hundred and fifty   thousand U.S. Dollars ($250,000)
    
	
(c)
    	
 
    	
Successful completion of Phase I Study in the United   States
    	
 
    	
Five hundred thousand   U.S. Dollars ($500,000)
    
	
(d)
    	
 
    	
Successful completion of Phase II Study in the   United States
    	
 
    	
One million U.S.   Dollars ($1,000,000)
    
	
(e)
    	
 
    	
[***]
    	
 
    	
[***]
    
	
(f)
    	
 
    	
[***]
    	
 
    	
[***]
    
	
(g)
    	
 
    	
[***]
    	
 
    	
[***]
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

8

 

provided always that each milestone payment shall be made only onetime regardless of how many times such milestone event is achieved or the number of indications for which the Product is approved, and no milestone payment shall be owed for a milestone event that is not achieved. Success for purposes of subsections (c), and (d) above shall be deemed to have occurred when Licensee decides to proceed to the next step of clinical development, as reflected in the above chart.

 

8.02                        In consideration for the rights with respect to each Product in the Territory granted under this Agreement by Licensor, Licensee shall pay to Licensor:

 

(i)             [***] percent ([***]%) of Net Sales of the Product during a Calendar Quarter, within sixty (60) days after the end of such Calendar Quarter and,

 

(ii)          the difference between (a) and (b) below within sixty (60) days after the end of a Calendar Year:

 

(a)                     the sum of (i) during a Calendar Year and,

 

(b)                     the total amount of;

 

(1)   [***]percent ([***]%) of Net Sales up to and including [***] U.S. Dollars ($[***]) during a Calendar Year,

 

(2)   [***] percent ([***]%) of Net Sales in excess of [***] U.S. Dollars ($[***]) up to and including [***] U.S. Dollars ($[***]) during a Calendar Year,

 

(3)   [***] percent ([***]%) of Net Sales in excess of [***] U.S. Dollars ($[***]) during a Calendar Year,

 

provided that for any Net Sales in a country in which there are no issued claims of a Licensor Patent in force which would be infringed by Licensee but for the licenses granted under this Agreement (“Non Patent Net Sales”), Licensee shall pay Licensor half of the amount calculated as above, provided further that during the extension period of this Agreement as set forth in Section 19.01, Licensee shall pay Licensor [***] percent ([***]%) of Net Sales of the respective Product in the respective country if such Product embodies Licensor Information which

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

9

 

has not entered the public domain through any action of AkaRx.

 

8.03                        Licensee shall be responsible for obtaining and making payment for any licenses for rights or obtaining any ownership rights to any Third Party’s intellectual property required to develop, commercialize, make, have made, use, sell, have sold, offer  to  sell  or  resell, import, export, distribute or otherwise transfer physic al possession of or otherwise transfer title in or to, the Compound and the Product Licensee shall be entitled to deduct [***] percent ([***]%) of such payments from amounts due to Licensor, whether license fees, milestone payments, royalties or as otherwise characterized until such deductible amount has been fully deducted; provided, however, no such deduction shall have the effect of reducing any payment made to Licensor by more than [***] percent ([***]%). In the event the Compound or the Product is sold in a particular country in a finished dosage form containing a Compound in combination with one or more other active ingredients or a proprietary delivery system (a “Combination Product”), the Net Sales of the Product in such form in such country, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in such country of the Product when sold separately in finished form and B is the weighted average sale price in such country of the other product(s) sold separately in finished form.  In the event that such average sale price cannot be determined in such country for both the Product and the other product(s) in combination, then the prices in the United States will be used, and if the Product is not sold in the United States then Net Sales for purposes of determining royalty payments shall be agreed by the Parties based on the relative values contributed by each component, such agreement not to be unreasonably withheld or delayed. Furthermore, if in any jurisdiction, Licensee is required by a governmental authority to grant a compulsory sublicense to a Third Party with royalty rates or upon royalty rates more favorable to such Third Party than applicable to Licensee under this Agreement, then the royalty rates and terms of this Agreement shall immediately and without the need for further action be deemed to be reduced to such rates for purposes of calculating royalties due in respect of Net Sales in such jurisdiction.

 

8.04                        All payments to be made by either Party under this Agreement shall be made in U.S. Dollars by bank wire transfer to a bank account designated in writing by the other Party.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

10

 

8.05                        Net Sales or other revenues received or expenses or payments due in currencies other than U.S. Dollars shall first be calculated in the relevant foreign currency and then converted to U.S. Dollars against the currency in question on the rate of exchange applicable on the last Business Day of the Calendar Quarter in respect of which the funds are payable using the currency exchange rates (Telegram Transfer Selling) quoted by Citibank, N.A. in New York, New York during the period of such Net Sales, or in the event that exchange rate is not available then as reported in the eastern U.S. edition of The Wall Street Journal.

 

8.06                        If Licensee fails to make a timely payment pursuant to this Article 8, interest shall accrue on the past due amount at a rate equal to the lesser of 110% of the prime rate of interest (or its equivalent) charged by Citibank, N.A. in New York, New York from time to time, or such lower maximum rate allowed by applicable law, from the first date on which the payment was delinquent, calculated on an actual/360 basis.

 

8.07                        If laws or regulations require withholding by Licensee of any taxes imposed upon Licensor on account of any royalties and advance payments paid under this Agreement, such taxes shall be deducted by Licensee as required by law from such payment and shall be paid by Licensee to the proper taxing authorities. Official receipts of payment of any withholding tax shall be secured and sent to Licensor as evidence of such payment.  The Parties will exercise their reasonable efforts to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of any applicable tax treaty.

 

9. COMMERCIALIZATION

 

9.01                        In no less than six (6) months after obtaining Regulatory Approval (including an approved price) from a Regulatory Authority, Licensee shall, or shall cause its Affiliates or sublicensees, to use commercially reasonable efforts to manufacture, promote, market, distribute and sell the Product in Territory in which such Regulatory Approval has been obtained at its own cost

 

9.02                        Licensee shall be responsible for responding to all questions or inquiries relating to the Product sold in Territory and, upon the request of Licensee, Licensor shall reasonably assist and co-operate in the preparation of any such responses.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

11

 

10. SUPPLY OF MATERIAL

 

10.01                 Licensor shall provide, or shall cause its Affiliates to provide (i) Licensor Material in possession of Licensor as of the Effective Date at the request of Licensee, to the extent that it is possible for Licensor to so provide and (ii) cGMP Compound and Non-cGMP Compound from among existing stocks as of the Effective Date. The Parties acknowledge that Licensor has in its possession approximately 7.9 kilograms of Compound manufactured in accordance with cGMP (“cGMP Compound”) and approximately 35 kilograms of Compound manufactured not in accordance with cGMP (‘‘Non-cGMP Compound”). Licensor agrees to sell to Licensee pursuant to a one-time purchase order delivered by Licensee to Licensor up to such amount of cGMP Compound as it may now have in its possession and to transfer to Licensee at no cost up to five (5) kilograms of Non-cGMP Product.  Promptly following execution and delivery of this Agreement, Licensor shall take stock of its supply of cGMP Compound and inform Licensee of the quantity on hand.

 

10.02                 Licensee shall submit one-time purchase order for cGMP Compound within ninety (90) days after the Effective Date to Licensor for fulfillment out of stock on hand at the time of the Effective Date of this Agreement. After consultation with Licensee, Licensor shall reasonably decide storage conditions, out-bound quality testing, ordering lead times, shipping methods, packaging, transit insurance and the like. cGMP Compound shall be delivered on the basis of Ex Works (Incoterms 2000), Licensor’ manufacturing site in Japan. All cGMP Compound delivered pursuant to this Agreement shall conform to the Specifications and shall have been manufactured in compliance with all applicable laws and cGMPs. Licensor shall cooperate with Licensee by providing access to and copies of such manufacturing and  quality records directly related to cGMP Compound supplied pursuant to Section 10.01 as Licensee may reasonably require in connection with the clinical development of the Product including providing Licensee an opportunity, to be exercised in Licensee’s discretion, to audit Licensor’s manufacturing records regarding the production of cGMP Compound during ordinary business hours of Licensor but such access and audit shall not be allowed more than once respectively, nor shall they be a11owed at all after the filing of the first NDA.

 

10.03                 In the event that any facilities, operations and laboratories of Licensor or any of

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

12

 

its Affiliates become the subject of an investigation or audit relating to the Compound or the Product by any Regulatory Authority, Licensor shall notify Licensee thereof promptly after receipt of a prior notice from such authorities. In the event Licensor or any of its Affiliates do not receive prior notice of said investigation or audit, Licensor shall notify Licensee as soon as practicable after becoming aware of said investigation or audit. Licensor shall provide Licensee with a reasonable description of each such investigation or audit, promptly after such investigation or audit, and with copies of any letters, reports, or other documents. Licensee, its Affiliate or designee shall have the right to be present at, or otherwise participate in, such investigation or audit.

 

10.04                 Licensee shall pay to Licensor, i) in consideration for Licensor Material supplied pursuant to Section 10.01, 13,500 U.S. Dollars per kilogram, and ii) in consideration for cGMP Compound supplied pursuant to Section 10.02, 13,500 U.S. Dollars per kilogram. Such payment shall be made by Licensee within sixty (60) days after the end of the Calendar Quarter in which the delivery of Licensor Material or cGMP Compound occurs respectively.

 

11. ACCOUNT AND AUDIT

 

11.01                 Licensee or its Affiliate shall deliver to Licensor within sixty (60) days after the end of each Calendar Quarter a written sales report for such Calendar Quarter, setting forth the gross invoiced price of the Product, itemized deductions therefrom and Net Sales on a country-by-country basis.

 

11.02                 Licensee agrees that it shall keep, and cause its Affiliates and sublicensees to keep, accurate records in sufficient detail to enable the amounts due to Licensor hereunder to be determined and, upon Licensor’s request, shall permit an independent certified public accountant, selected by Licensor, except to whom Licensee, its Affiliate or sublicensee has reasonable objection, to have access during ordinary business hours to such of Licensee’s, its Affiliates’ or sublicensees’ records but such access shall not be allowed more than once per Calendar Year:

 

(a)                                 to determine, in respect to any Calendar Year, the correctness of any report and/or payment made under this Agreement, and

 

(b)                                 to obtain information as to the amount payable to Licensor for any such

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

13

 

Calendar Year in the case of Licensee’s or its Affiliate’s failure to report and/or make payment pursuant to this Agreement.

 

Any review by Licensor shall beat Licensor’s sole expense. This right of review shall terminate two (2) years after Licensor’s receipt of each respective sales report. The records for any particular Calendar Year shall only be subject to one audit. Such independent certified public accountant shall not disclose to Licensor any information other than information relating to the accuracy of reports and payments made under this Agreement and in no event are the quantities and prices to individual customers or the names of those customers to be disclosed to Licensor.

 

11.03                 In the event of a determination by such independent certified public accountant that there has been an inaccurate calculation or payment, an appropriate adjustment shall be made to the next payment.

 

12. OWNERSHIP

 

12.01                 Licensor shall solely own all right, title and interest in and to the Licensor Patents, Licensor Know-How and Licensor Information, subject to the rights and licenses granted to Licensee under this Agreement.

 

12.02                 All results, data, information, know-how and technology obtained in the course of, or related to, research and development activities of the Compound or Product conducted by Licensee or any of its Affiliates or sublicensee or the manufacturing process for the Compound or Product developed by Licensee or any of its Affiliates or sublicensee shall be solely owned by Licensee.

 

12.03                 Other than as expressly set forth in this Agreement, neither Party shall have any right in and to any intellectual property owned or controlled by the other Party and, save as set out in this Agreement, neither Party shall have an obligation to license any rights in or to its intellectual property to the other Party.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

14

 

13. PROSECUTION AND MAINTENANCE OF INTELLECTUAL PROPERTY RIGHT

 

13.01                 Licensee shall hereby assume from Licensor all responsibility and control for the preparation, filing, prosecution and maintenance as well as any cost to be incurred therefor of all relevant patent applications and patents included or to be included within the Licensor Patents and applications for patent extension or supplementary protection certificates or similar extensions in the name of Licensor, if required, for the benefit of Licensee. Licensee shall provide Licensor with copies of relevant documentation so that Licensor can be informed of continued prosecution and shall permit Licensor to comment on such documentation to the extent it relates to the Product or Compound. Licensee shall give due consideration to any reasonable comments by Licensor.

 

13.02                 Notwithstanding Section 13.01, Licensee shall have the right, at any time and at its sole option, to elect not to proceed with and/or to abandon filing, prosecution, and/or maintenance of any Licensor Patents, provided that Licensee shall give Licensor notice of such intention at least thirty (30) days before a final due date which would result in the abandonment, cancellation or lapse of an issued patent or pending patent application. In such case, Licensor, at its option, may assume the right to prepare, file, prosecute, maintain and/or defend any such Licensor Patents at Licensor’s expense.

 

13.03                 To the extent it relates to the Product or Compound, each Party agrees to co- operate with the other Party in the preparation, filing, prosecution, maintenance and defense of Licensor Patents and application for patent extension or supplementary protection certificates or the similar procedures, including the signing of any necessary legal papers, and to provide the other Party with data or other information in support thereof, and to use reasonable efforts to ensure the co-operation of any of their respective personnel as might reasonably be requested in any such matters.

 

13.04                 The trademark for the Product shall be selected by Licensee or its Affiliate at their sole discretion and registered and owned by Licensee or its Affiliate.

 

14. ENFORCEMENT

 

14.01                 If either Party learns of any infringement or threatened infringement by a Third Party of a Licensor Patent, such Party shall promptly notify the other Party in writing and shall provide such other Party with available evidence of such 

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

15

 

infringement,

 

14.02                 Licensee, at its expense, shall have the exclusive right but not the obligation to initiate and prosecute any action or proceeding with respect to infringement of any Licensor Patent in the Territory (“Action”) and Licensor shall be joined as a plaintiff to any such Action if Licensee so requests, at Licensee’s expense.

 

14.03                 Licensee shall, subject to prior consultation with Licensor, have the right to determine the strategy and to exclusively control the Action.

 

14.04                 Any damages or other monetary awards recovered from an Action shall be allocated first to reimburse the costs and expenses of Party who brings the Action and, if the other Party joins as a party plaintiff, then the costs and   expenses of the other Party. Any amounts remaining shall be paid to Licensor to the extent such damage represents a loss of royalties or loss of profit from the royalty and any remaining balance shall be paid to Licensee.

 

15. DEFENSE

 

15.01                 Licensee, at its own expense and subject to prior consultation with Licensor, shall control and conduct the defense against any actual, alleged or threatened claim or action which names Licensor and/or Licensee and which claims the infringement of Third Party’s patent rights or know-how through importing, using, manufacturing, and marketing, selling, leasing and/or distributing the Compound or the Product. Licensee shall not settle or compromise such proceedings that would affect Licensor’s rights or interests, without the prior written consent of Licensor which shall be neither unreasonably withheld or delayed. When named, Licensor shall be entitled, at its own expense, to participate in and to have counsel selected by it participate in any action.

 

15.02                 In the event Licensee fails within a reasonable time to initiate appropriate action in connection with the defense which in the reasonable judgment of Licensor adversely affects or might adversely affect Licensor’s rights or interests, Licensor upon notice to Licensee shall have the right, but not the obligation, to initiate or pursue any such appropriate action in Licensor’s name and at Licensee’s expense, and Licensee shall cooperate fully in any such act ion, provided, however, that Licensee at all the time shall have the right to fully participate in

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

16

 

such action at its own expense. Any judgment, damages, settlement or award which results from any action shall be paid by Licensee.

 

16. REPRESENTATIONS AND WARRANTIES

 

16.01                 Licensor represents and warrants to Licensee that:

 

(a)         Licensor is a corporation duly incorporated, validly existing and in good standing under the law of the jurisdiction of its organization, and has the power to perform its obligations and to carry on its business under this Agreement.

 

(b)         This Agreement has been duly executed and delivered by Licensor, is a legal and valid obligation binding upon Licensor and enforceable against Licensor in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance and other laws affecting creditors’ rights generally or by the availability of equitable remedies.

 

(c)          The execution, delivery and performance of this Agreement by Licensor is within the corporate power of Licensor, has been duly authorized by all necessary corporate action, does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

(d)         As of the Effective Date, Licensor has not knowingly withheld any material information from Licensee in response to Licensee’s reasonable inquiries in connection with Licensee’s due diligence relating to the Compound or the Product and this Agreement.

 

(e)          As of the Effective Date, to the Knowledge of Licensor, (i) there is no pending litigation which alleges or any written communication alleging that Licensor’s activities with respect to the Compound or the Product have infringed or misappropriated any of the intellectual property rights of any Third Party, (ii) all fees required to be paid by Licensor in order to maintain the Licensor Patents have been paid to date, and (iii) it has not previously

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

17

 

assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensor Patents or the Licensor Information, and (iv) there is no pending proceeding which alleges or any written communication alleging that the issued claims contained within the Licensor Patents are not valid and that the pending claims within the Licensor Patents, if and when issued, will not be valid.

 

(f)           Licensor has the right to grant the rights granted to Licensee under this Agreement.

 

(g)          Licensor bas received no notices that Licensor’s granting of the rights granted to Licensee under this Agreement, or Licensor’s performing its obligations to Licensee under this Agreement, is in breach of its obligations under any agreement with a Third Party.

 

(h)         As of the Effective Date, to the Scientific Knowledge of Licensor, the data of the study report (No. D200201688-01.00) included in Licensor Information which show that YM477 does not inhibit thrombopoietins from binding to the Mpl receptor up to a concentration of 100 μ. M are valid and scientifically sound.

 

16.02                 Licensee represents and warrants to Licensor that:

 

(a)         Licensee is a corporation duly organized, validly existing and in good standing under the law of the jurisdiction of its organization, and has the power to perform its obligations and to carry on its business under this Agreement

 

(b)         Th.is Agreement has been duly executed and delivered by Licensee, is a legal and valid obligation binding upon Licensee and enforceable against Licensee.in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance and other laws affecting creditors’ rights generally or by the availability of equitable remedies.

 

(c)          The execution, delivery and performance of this Agreement by Licensee is within the corporate power of Licensee, has been duly authorized by at1

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

18

 

necessary corporate action, does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

16.03                 THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING, WITH-OUT LIMITATION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS) EXCEPT AS SPECIFICALLY PROVIDED IN THIS AGREEMENT AND EXCEPT FOR CLAIMS OF FRAUD AND FRAUDULENT INDUCEMENT.

 

16.04                 All claims by either Party for breach or default by the other Party under this Agreement shall be brought within one (1) year after the cause of action accrued or shall be deemed waived.

 

17. INDEMNIFICATION

 

17.01                 Licensee shall indemnify and hold Licensor and its Affiliates, its directors, officers, employees and agents (as well as those of its Affiliates) harmless from and against all suits, investigations, claims, damages, liabilities, losses, costs and expenses, including but not limited to payment of reasonable attorneys’ fees and expenses and court costs (collectively “Loss”) resulting from any and all Third Party claims for damage or injury to persons or property or for loss of life caused by (i) the use, sale and distribution of the Compound or the Product by Licensee, its Affiliates or its sublicensees hereunder, (ii) any negligence or willful misconduct of Licensee, its Affiliates or its sublicensees or (iii) infringement of Third Party intellectual property rights by the exercise of any rights by Licensee, its Affiliates or sublicensees pursuant to this agreement; provided however, that if such Loss is caused partially or solely by (i) any gross negligence or willful misconduct of Licensor or any of its Affiliates, (ii) failure of the CGMP

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

19

 

Compound supplied by Licensor or any of its Affiliates to meet the Specifications or applicable cGMPs or (iii) material breach of this Agreement by Licensor or its Affiliates, Licensee shall not be obligated under this Section to the extent such Loss has resulted therefrom and Licensor shall indemnify and hold Licensee and its Affiliates, directors, officers, employees and agents (as well as those of its Affiliates) harmless from and against all such Losses to the extent of Licensor’s fault.

 

17.02                 In the event that a Party receives notice of a claim, lawsuit, or liability by a Third Party for which the other Party is entitled to indemnification, the indemnified Party shall give prompt written notification to the indemnifying Party. The indemnifying Party shall keep the indemnified Party informed as to the progress of its defense of any such claim, lawsuit or liability and the indemnifying Party shall have complete control over the conduct and disposition of the claim, lawsuit, or liability including the retention of legal counsel engaged to handle such matter, provided that the indemnifying Party shall not settle or compromise such claim, lawsuit, or liability that would affect the indemnified Party’s rights or interests, without the prior written consent of the indemnified Party.

 

17.03                 During term and for a period of five (5) years after expiration or termination of this Agreement, Licensee shall secure and maintain an insurance policy underwritten by a reputable insurance company and in a form and having limits standard and customary for entities in the biopharmaceutical industry for exposures related to products such as the Product

 

18. CONFIDENTIALITY

 

18.01                 During the term of this Agreement and for a period of ten (10) years after termination or expiration of this Agreement, neither Party shall disclose to Third Parties or use, except as may be provided for under this Agreement, any Confidential Information without express prior written consent of the other Party; provided, however, that the foregoing restrictions on disclosure and use shall not apply to any Confidential Information which:

 

(a)                                 at the time of disclosure can be demonstrated by competent evidence to be already known to the receiving Party;

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

20

 

(b)                                 at the time of disclosure or subsequent thereto is in the public domain other than by an act or omission on the part of the receiving Party charged with the non-disclosure obligation;

 

(c)                                  is acquired from or made available by a Third Party having the lawful right to disclose such information; or

 

(d)                                 has been independently developed by employees or contractors of the receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the disclosing Party.

 

18.02                 Notwithstanding Section 18.01, the Parties shall be permitted to disclose the Confidential Information (a) as required to be disclosed in seeking any Regulatory Approvals required in connection with the importation, exportation, offer for sale, sale, marketing, manufacturing, and/or use of the Product; (b) to consultants, clinicians, or others in connection with the performance of consulting services or laboratory or clinical studies necessary for the filing of applications for such approvals; (c) as reasonably necessary for purposes of marketing and promoting the Product; (d) to comply with applicable laws and regulations or (e) as required to be disclosed in a judicial or administrative proceeding, provided that the disclosure under (b) shall be further subject to appropriate confidentiality agreements and that each Party shall give a written notice to the other prior to the disclosure under (d) or (e). Information licensed exclusively by Licensor to Licensee pursuant to this Agreement shall continue to be the information of Licensor, but, Licensor shall not use or disclose such Information to Third Parties without express prior written consent of Licensee; provided, however, that (I) the foregoing restrictions on Licensor shall not apply to any Information which falls in ant of 18.01 (a), (b), (c) or (d) and that (II) Licensor may make publication presentation or other public announcement regarding research, studies and activates of Licensor and containing such Information if consented by Licensee in advance, which consent shall not be unreasonably withheld or delayed

 

18.03                 Licensor shall have the right to disclose Confidential Information to any Affiliate of Licensor, and Licensee shall have the right to disclose Confidential Information to any of its Affiliates and sublicensees, provided that such disclosure shall be subject to obligations of confidentiality comparable to those contained herein and further that such disclosure does not violate any applicable 

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

21

 

anti-trust laws within Territory.

 

18.04                 Neither Party shall make any press release or other public announcement or other disclosure to a Third Party concerning any results, data, information, know-how and technology regarding research, studies and activities of the other Party in connection with this Agreement and the existence of or tern1S of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. The foregoing shall not be construed to preclude any disclosure required to be made by applicable law, rule or regulation.

 

19. TERM

 

19.01                 This Agreement shall commence on the Effective Date and, unless sooner terminated in accordance with the terms hereof, continue in effect on a country-by-country basis and on a product-by-product basis for a period of the longer of (i) until the expiration of the last-to-expire claim of a Licensor Patent, (ii) any government-granted marketing exclusivity period for the Product or (iii) ten (10) years after the last Date Of Launch to have occurred in any country in Territory.  Thereafter, this Agreement may be extended for successive terms of one year each if Licensee expresses its desire in writing to extend the term of this Agreement at least three (3) months prior to the expiry date of this Agreement.

 

20. TERMINATION

 

20.01                 Licensee shall be entitled, upon thirty (30) days prior written notice to Licensor, to terminate this Agreement in whole, or on a country by country basis, in writing at any time without penalty.

 

20.02                 This Agreement may be terminated whether in whole or as to one or more countries in Territory with written notice by either Party at any time during the term of this Agreement

 

(a)                                 if it is proven by reasonable evidence that the other Party is in breach of its material obligations hereunder for reasons other than force majeure and has not cured such breach within sixty (60) days after submission of written notice requesting the correction of the breach; or

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

22

 

(b)                                 upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings by the other Party or upon the failure by the other Party for more than sixty (60) days to take steps to oppose the initiation of such actions against it.

 

20.03                 This Agreement may be terminated by Licensor with written notice for the countries in which both of the following events have occurred:  i) Licensee has elected not to proceed with and/or abandoned filing, prosecution, and/or maintenance of Licensor Patents in accordance with Section 13.02, and ii) Licensee has failed to commercialize the Product in five (5) years after Licensee obtains the first Regulatory Approval from a Regulatory Authority.

 

20.04                 Upon termination of this Agreement for whatever reasons, Licensee, its Affiliates and/or sublicensees shall pay in full all sums due to Licensor before the termination of this Agreement within thirty (30) days of the date of termination. Licensee shall not be obligated to pay any milestone payments if the relevant milestone event does not occur before the termination of this Agreement for whatever reason.

 

20.05                 Upon termination of this Agreement by Licensee pursuant to Section 20.01 or by Licensor pursuant to Section 20.02 or Section 20.03, Licensee shall promptly take the following measures in each country in the Territory where this Agreement is terminated:

 

(a)                                 cease to use the Licensor Patents and the Licensor Know-How in those jurisdictions where this Agreement has been terminated;

 

(b)                                 return to Licensor or its designee, destroy or transfer to a country where this Agreement remains in full force and effect all the Licensor Information and Licensor Material supplied by Licensor hereunder;

 

(c)                                  transfer all the registrations of the Product in terminated countries of the Territory including the NDA if applicable and legally possible, and any related information and know-how prepared by Licensee and its Affiliate to Licensor or its designee to enable Licensor or its designee to sell the Product as soon as practicable in such terminated countries of the 

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

23

 

Territory;

 

(d)                                 cease to use and sell the Product in the terminated countries of the Territory within one hundred eighty (180) days of termination;

 

(e)                                  (i) at Licensor’s request, destroy or return to Licensor all the Product on band in terminated countries of the Territory at Licensee’s own expense after Licensee has had the opportunity to sell off the same during the one hundred eighty (180) day period following termination or (ii) Licensee shall promptly transfer all such Product to a country of the Territory where this Agreement remains in full force and effect; and

 

(f)                                   grant to Licensor an exclusive license to use the trademark owned or controlled by Licensee for the Product, but only in terminated countries of the Territory, for the purpose of commercialization of the Product in such countries, provided that, Licensor shall pay Licensee a royalty equal to [***] percent ([***]%) of the net sales invoiced for sales of the Product by Licensor and its Affiliates to Third Parties.

 

20.06                 Notwithstanding the provision of Section 18.01, Licensor and its designees shall be entitled to use free of charge the registrations including the NDA and related information and know-how prepared by Licensee and its Affiliate, and transferred to Licensor or its designee under the provision of Section 20.05(c).

 

21. GENERAL PROVISIONS

 

21.01                 FORCE MAJEURE

 

The Parties shall not be liable for any failure of or de]ay in performing any obligation under this Agreement, if such failure or delay is due to acts of God, weather, earthquakes, fire, explosion; war, invasion, riot or other civil unrest; governmental laws, orders, restrictions, actions, embargoes or blockades; rational or regional  emergency; injunctions, strikes, lockouts, labor trouble or other industrial disturbances; or any other cause beyond the control of the affected Party; provided, however, that the Party affected shall promptly notify the other Party of the force majeure and shall exert its best efforts to eliminate, cure or overcome any such causes and to resume performance of its obligations with all possible speed.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

24

 

21.02                 SURVIVAL

 

Termination or expiration of this Agreement will not affect Articles 17 (INDEMNIFICATION), 18 (CONFIDENTIALITY), 21.04 (GOVERNING LAW), 2l.05 (ARBITRATION) or any terms and conditions meant to survive such termination or expiration.

 

21.03      ASSIGNMENT

 

Neither of the Parties may assign, transfer or otherwise dispose of this Agreement to any Third Party without the prior written consent of the other party; provided, however, that each Party shall have the right to assign its rights and obligations under this Agreement to any Third Party successor to all or substantially all of (x) its entire business or (y) its pharmaceutical business. Notwithstanding the foregoing, either Party may assign this Agreement in whole or in part or extend the benefits thereof to any of its Affiliate(s) who shall be substituted directly in whole or in part for it hereunder, provided, however, that the assignor shall guarantee the performance of its Affiliate assignee hereunder.

 

21.04      GOVERNING LAW

 

This Agreement shall be deemed to have been made in the State of New York and its form, execution, validity, construction and effect shall be determined in accordance with the laws of the State of New York, U.S.A.

 

21.05      ARBITRATION

 

In the event of any controversy or claim arising out of or relating to this Agreement or breach thereof, the Parties shall try to settle those conflicts amicably between themselves.  Should they fail to agree, the matter in dispute shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators appointed in accordance with said Rules. The language of any arbitration proceeding shall be English. The award rendered by the arbitrator(s) shall be final and binding upon the Parties hereto.  The place of arbitration shall be in Tokyo, Japan.

 

21.06      NOTICE

 

Notice to Licensor shall be addressed to:

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

25

 

Astellas Pharma Inc.

3-11, Nihonbashi-Honcho 2-chome

Chuo-ku, Tokyo 103-841l

Japan

Attention:

 

with a copy to:

 

Notice to Licensee shall be addressed to:

 

AkaRx Corp.

Mack Centre IV, 4th Floor

61 S. Paramus Road

Paramus, NJ  07652

Attn.

 

with a copy to:

 

Heller Ehrman LLP

4350 La Jolla Village Drive, 7th Floor

San Diego, CA  92122

Attn:  Richard A. Kaufman

 

Either Party may change its address by giving written notice to the other Party in advance.

 

Any notice or request required or permitted to be given in connection with this Agreement shall be in writing and shall be deemed to have been sufficiently given if sent by prepaid registered or certified air mail or personal courier at the address set forth in this Section 21.06 or to such other business address as may have been furnished in writing by the intended recipient to the sender. The date of notice shall be deemed to be the date on which such notice has been given. Any required notice shall be given in the English language.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

26

 

21.07      WAIVER

 

The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provisions on such occasion or any succeeding occasion. No waiver of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Party waiving such obligation or provision.

 

21.08      ENTIRE AGREEMENT AND AMENDMENTS

 

This Agreement contains the entire agreement between the Parties in respect to the license of the Product and supersedes and cancels all previous agreements, negotiations, commitments and writings in respect to the subject matter hereof, including but not limited to, the relevant part of the MOU  and may not be changed or modified in any manner, or released, discharged, abandoned, or otherwise terminated, orally or otherwise, unless in writing and signed by the duly authorized representatives of the Parties.

 

21.09      SEVERANCE

 

If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

 

21.10      INTERPRETATION

 

The titles of the Articles and Sections of this Agreement are for general information and reference only, and this Agreement shall not be construed by reference to such titles. All exhibits are incorporated into and made a part of this Agreement by reference. The term “including” (or any variation thereof such as “include”) shall be without limitation.

 

21.11      THIRD PARTY BENEFICIARIES

 

None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including, without limitation, any creditor of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

27

 

claim in respect of any debt, liability or obligation (or otherwise) against either party hereto.

 

21.12                 LEGAL COMPLIANCE

 

Each Party shall comply in all material respects with all laws, rules and regulations applicable to the conduct of its business in Territory pursuant to this Agreement.

 

21.13                 RELATIONSHIP OFTHE PARTIES

 

Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute Licensee and Licensor as partners, agents or joint ventures. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Third Party.

 

21.14      COUNTERPARTS

 

This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document.  All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

28

 

IN WITNESS WHEREOF, the Parties have executed this Agreement by the signature of their duly authorized representatives on the date written above.

 

	
ASTELLAS PHARMA INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/ Toichi Takenaka
    	
 
    
	
Name
    	
Toichi Takenaka
    	
 
    
	
Title
    	
President and CEO
    	
 
    

 

 

	
AKARX, INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/ Robert E.   Desjardins
    	
 
    
	
Name
    	
Robert E. Desjardins
    	
 
    
	
Title
    	
President &   CEO
    	
 
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

29

 

Appendix A

 

(Licensor Patent)

 

A)            Basic Patent (reference number: Y0302)

	
[summary of the   invention]
    	
[***]
    
	
[priority   application]
    	
JP 2002-10413 filed on January 18, 2002
    
	
 
    	
JP 2002-10447 filed on January 18, 2002
    
	
[PCT   application]
    	
PCT/JP03/00270 filed on January 15, 2003
    
	
[non-PCT   application]
    	
none
    
	
[International   publication]
    	
WO 03/062233 published on July 31, 2003
    
	
[pending   country]
    	
JP, US, EP, CA, CN, KR, IN
    
	
[details]
    	
 
    

 

	
country
    	
 
    	
filing 
   date
    	
 
    	
application number
    	
 
    	
publication number
    	
 
    	
patent 
   number
    	
 
    	
Status
    
	
Japan
    	
 
    	
15JAN03
    	
 
    	
2003-562111
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    
	
United States
    	
 
    	
15JAN03
    	
 
    	
unassigned
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    
	
Europe
    	
 
    	
15JAN03
    	
 
    	
03 700 571.7
    	
 
    	
EP 1 466 912
    	
 
    	
—
    	
 
    	
pending
    
	
Canada
    	
 
    	
15JAN03
    	
 
    	
SN 2,472,711
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    
	
China
    	
 
    	
15JAN03
    	
 
    	
03 804 457.9
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    
	
Korea
    	
 
    	
15JAN03
    	
 
    	
2004-7010846
    	
 
    	
KR 2004-0078122
    	
 
    	
—
    	
 
    	
pending
    
	
India
    	
 
    	
15JAN03
    	
 
    	
00942/KOLNP/2004
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    

 

B)            Salt Patent (reference number:  Y0355)

	
[summary of the   invention]
    	
[***]
    
	
[priority   application]
    	
JP 2002-284689 filed on September 30, 2002
    
	
[PCT   application]
    	
PCT/JP2003/012419 filed on September 29, 2003
    
	
[non-PCT   application]
    	
none
    
	
[International   publication]
    	
WO 2004/029049 published on April 8, 2004
    
	
[pending   country]
    	
JP
    
	
[details]
    	
 
    

 

	
country
    	
 
    	
filing date
    	
 
    	
application number
    	
 
    	
publication number
    	
 
    	
patent 
   number
    	
 
    	
Status
    
	
Japan
    	
 
    	
29SEP03
    	
 
    	
2004-539569
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

AMENDMENT NO. 1

 

TO THE YM477 LICENSE AGREEMENT

 

This AMENDMENT NO. 1 TO THE YM477 LICENSE AGREEMENT (the “Amendment”), is entered into as of March 8, 2007 (the “Amendment Effective Date”) by and among Astellas Pharma Inc., a company organized and existing under the laws of Japan and having its principal office at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (“Licensor”), and AkaRx Corp., a company organized and existing under the laws of Delaware and having its principal office at Mack Centre IV, 4th Floor, 61 S. Paramus Road, Paramus, NJ 07652 (“Licensee”). Licensor and Licensee are referred to collectively herein as the “Parties”.

 

Whereas, the Parties entered into the YM477 License Agreement (the “Agreement”) as of August 15, 2005 wherein Licensee obtained a license to the Licensor Patents which included the patents/patent applications identified in Appendix A attached thereto;

 

Whereas, the Parties wish to add to the Licensor Patents (i) the one (1) additional patent family identified on Schedule A hereto (the “Additional Patent Filings”);

 

Whereas, the Parties wish to amend the Agreement to reflect the additions to the Licensor Patents identified in the Agreement; and

 

Now, therefore, in consideration of the mutual covenants and promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1.                                                                          DEFINITIONS

 

Capitalized terms used but not defined in this Amendment have the meaning given them in the Agreement.

 

2.                                                                          AMENDMENT TO AGREEMENT

 

The Parties agree that, subject to Paragraphs 3, 4, 5 and 6 below, the Licensor Patents of the Agreement were amended to include the Additional Patent Filings of Schedule A, attached hereto, as of November 8, 2005.

 

3.                                                                          DEFINITION OF “COMPOUND”

 

The definition of the Compound provided for in Article 1 of the Agreement shall be amended as follows:

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

““Compound” shall mean [***] together with all other compounds covered by the Licensor Patents designated in Appendix A attached to the Agreement, which Licensor Patents shall not  include any of the Additional Patent Filings solely for purposes of the definition of “Compound.””

 

4.                                                                          PROSECUTION AND MAINTENANCE OF LICENSOR PATENTS

 

Section 13.01 and 13.02 shall be amended as follows:

 

“13.01    Licensee shall hereby assume from Licensor all responsibility and control for the preparation, filing, prosecution and maintenance as well as any cost to be incurred therefor of all relevant patent applications and patents included or to be included within the Licensor Patents and applications for patent extension or supplementary protection certificates or similar extensions in the name of Licensor, if required, for the benefit of Licensee. Licensee shall provide Licensor with copies of relevant documentation so that Licensor can be informed of continued prosecution and shall permit Licensor to comment on such documentation. Licensee shall give due consideration to any reasonable comments by Licensor.

 

13.02                 Notwithstanding Section 13.01, Licensee shall have the right, at any time and at its sole option, to elect not to proceed with and/or to abandon filing, prosecution, and/or maintenance of any Licensor Patents, provided that Licensee shall give Licensor notice of such intention at least thirty (30) days before a final due date which would result in the abandonment, cancellation or lapse of an issued patent or pending patent application. In such case, Licensor, at its option, may assume the right to prepare, file, prosecute, maintain and/or defend any such Licensor Patents at Licensor’s expense. While the terms and conditions mentioned above in this Section 13.02 shall be applied, in principle, to filing, prosecution, and/or maintenance of a Licensor Patent as a whole (not any portion thereof), they shall also be applied to filing, prosecution, and/or maintenance of any portion of an Additional Patent Filing if such portion covers any compound or product other than the Compound or the Product.”

 

5.                                                                          ENFORCEMENT OF LISENSOR PATENT

 

Section 14.02 shall be amended as follows:

 

“Licensee, at its expense, shall have the exclusive right but not the obligation to initiate and prosecute any action or proceeding with respect to infringement of any Licensor Patent in the Territory (“Action”) and Licensor shall be joined as a plaintiff to any such Action if Licensee so requests, at Licensee’s expense; provided, however, that any action or proceeding with respect to infringement of any Additional Patent Filing shall be excluded from the Action if such infringement is not upon the portion(s) of the Additional Patent Filing covering the Compound or the Product, and Licensor shall have the sole and exclusive right but not the obligation to initiate, prosecute and otherwise control such action or proceeding (which is not the Action) and may retain all damages or other  monetary award  recovered from such action or proceeding to the exclusion of Licensee.”

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

6.                                                                          REPRESENTATION AND WARRANTIES AS TO LICENSOR PATENT

 

Notwithstanding Paragraph 2 above, the provisions of Section 16.0l(e)(ii) shall not be applied to the Additional Patent Filings and Section 16.0l(e)(iv) with respect to the Additional Patent Filings will exclude patent office proceedings, patent office search reports and patent office examination reports from the representations and warranties.

 

7.                                                                          FULL FORCE AND EFFECT

 

The Agreement, as amended by this Amendment and effective as of the Amendment Effective Date, remains in full force and effect.

 

IN WITNESS WHEREOF, the Parties’ authorized representatives have executed this Amendment.

 

 

	
ASTELLAS PHARMA INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Name
    	
/s/ Masaki Doi
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Masaki Doi, Ph.D.
    	
 
    
	
 
    	
 
    	
 
    
	
Title
    	
Vice President,   Business Development
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
AKARX, INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Name 
    	
/s/ Robert E. Dejardins
    	
 
    
	
 
    	
 
    	
 
    
	
Title   
    	
CEO
    	
 
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

SCHEDULE A

 

A)                     Additional Patent Filings

 

[title of the invention] [***]

 

[priority application] U.S Application No. 60/734,426 filed on November 8, 2005

 

[PCT application] PCT/IB2006/003142 filed on November 7, 2006

 

[non-PCT application] U.S. Application No. 11/593,758 filed November 7, 2006

 

[International publication]

 

[pending country] US, PCT

 

[details]

 

	
Country
    	
 
    	
Filing date
    	
 
    	
Application Number
    	
 
    	
Publication
   Number
    	
 
    	
Patent
   Number
    	
 
    	
Status
    
	
United States
    	
 
    	
07NOV06
    	
 
    	
11/593,758
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    
	
PCT
    	
 
    	
07NOV06
    	
 
    	
PCT/IB2006/003142
    	
 
    	
—
    	
 
    	
—
    	
 
    	
pending
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

AMENDMENT N0.2 TO YM477 LICENSE AGREEMENT

 

This Amendment No.2 (this “Amendment”) is made and entered as of October 10, 2007 (“Effective Date”) by and between Astellas Pharma Inc., a company organized and existing under the laws of Japan and having its principal office at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (“Licensor”) and AkaRx, Inc., a company organized and existing under the laws of Delaware and having its principal office at Mack Centre IV, 4th Floor, 61 S. Paramus Road, Paramus, NJ 07652 (“Licensee”).

 

RECITALS

 

A.                                            Licensor and Licensee entered into a certain YM477 License Agreement dated as of August 15, 2005 (the “License Agreement”) and the AMENDMENT No.1 TO THE YM477 LICENSE AGEEMENT dated as of March 8, 2007.

 

B.                                           Licensor and Licensee now desire to amend the License Agreement.

 

NOW THEREFORE, Licensor and Licensee agree to amend the License Agreement as follows:

 

1.                                           The article 10 (SUPPLY OF MATERIAL) of the License Agreement is hereby amended to add a new Sections 10.05 and 10.06 which shall read as follows:

 

“10.05                                                               Licensor agrees to sell to Licensee pursuant to a one-time purchase order delivered by Licensee to Licensor twenty-nine point nine (29.9) kilograms of Non-cGMP Compound. Licensee shall submit such one-time purchase order to Licensor within one hundred and eighty (180) days after the Effective Date. After consultation with Licensee, Licensor shall reasonably decide ordering lead times, shipping methods, packaging, transit insurance and the like with respect to such sale. Such Non-cGMP Compound shall be delivered on the basis of Ex Works (Incoterms 2000), Licensor’ manufacturing site in Japan. Licensee shall pay to Licensor, in consideration for Non-cGMP Compound supplied pursuant to this Section 10.05, 8,500 U.S. Dollars per kilogram. Such payment shall be made by Licensee within sixty (60) days after the delivery of Non-cGMP Compound occurs.

 

10.06                                                                     ALL THE NON-CGMP COMPOUNDS ARE PROVIDED TO LICENSEE “AS IS” WITHOUT WARRANTY OF ANY KIND.  TO THE MAXIMUM EXTENT ALLOWABLE BYLAW, LICENSOR EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, AS TO ANY ASPECT OF NON-CGMP COMPOUND OR ITS USE AND DELIVERY, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE.”

 

2.                                           Except as amended and supplemented hereby, the License Agreement shall remain in full force and effect.

 

3.                                           This Amendment shall come into effect on the Effective Date of this Agreement and continue until the expiration or termination of the License Agreement.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

4.                                          This Amendment may be executed in counterparts, each such counterpart constituting an original and all such counterparts constituting on and the same agreement.

 

IN WITNESS WHEREOF, the parties have caused this Amendment to be duly executed and delivered by their proper and duly authorized officers as of the date and year first written above.

 

	
LICENSEE:
    	
 
    
	
 
    	
 
    
	
AKARX, INC.
    	
 
    
	
 
    	
 
    
	
By:   
    	
/s/   Robert Desjardins
    	
 
    
	
Name:   
    	
Robert   Desjardins, MD
    	
 
    
	
Title:
    	
President   and Chief Executive Officer
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
LICENSOR:
    	
 
    
	
 
    	
 
    
	
ASTELLAS PHARMA INC.
    	
 
    
	
 
    	
 
    
	
By:     
    	
/s/   Hirofumi Onosaka
    	
 
    
	
Name:   
    	
Hirofumi   Onosaka
    	
 
    
	
Title:
    	
Senior   Corporate Officer
    	
 
    
	
 
    	
CFO &   Chief Strategy Officer
    	
 
    
				

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

AMENDMENT N0.3

 

TO THE YM477 LICENSE AGREEMENT

 

This AMENDMENT N0.3 TO THE YM477 LICENSE AGREEMENT (the “Amendment”), is  entered into as of this 12th day of March, 2012 (the “Amendment Effective Date”) by and between Astellas Pharma Inc., a company organized and existing under the laws of Japan and having its principal office at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (“Licensor”), and AkaRx, Inc., organized and existing under the laws of Delaware and having its principal office at 100 Tice Blvd., Woodcliff Lake, NJ, a wholly-owned subsidiary of Eisai Inc., (“Licensee”). Licensor and Licensee are referred to collectively herein as the “Parties”.

 

Whereas, the Parties entered into YM477 License Agreement as of August15, 2005, the Amendment No. 1 on March 8, 2007 and Amendment No. 2 as of October 10, 2007 (collectively the “License Agreement”), under which AkaRx Inc. received exclusive license rights to the Licensor Patents (as defined in the License Agreement);

 

Whereas, the Parties now wish to add one (1) additional patent family identified on Schedule A hereto (the “Polymorph Additional Patent Filings”) to the Licensor Patents; and

 

Whereas, the Parties wish to amend the License Agreement to reflect such additions to the definition of Licensor Patents in the License Agreement;

 

Now, therefore, in consideration of the mutual covenants and promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1.               DEFINITIONS

 

Capitalized terms used but not defined in this Amendment have the meaning given them in the Agreement.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

2.               AMENDMENT TO AGREEMENT

 

The Parties agree that, effective as of August 3, 2011, the Polymorph Additional Patent Filings described on Schedule A, attached hereto, shall be included as Licensor Patents under the License Agreement.

 

3.                  DEFINITION OF “COMPOUND”

 

The definition of the Compound provided for in Article I of the License Agreement shall be amended as follows:

 

““Compound” shall mean [***] including for the avoidance of doubt, any polymorph forms thereof, and all other compounds, covered by the Licensor Patents.”

 

4.              FULL FORCE AND EFFECT

 

The Agreement, as amended by this Amendment and effective as of the Amendment Effective Date, remains in full force and effect until expiration or termination of the License Agreement.

 

IN WITNESS WHEREOF, the Parties’ authorized representatives have executed this Amendment.

 

 

	
Astellas   Pharma Inc.
    	
 
    	
AkaRx, Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/   C Yokota
    	
 
    	
/s/   Vincent P. Andrews
    
	
 
    	
 
    	
 
    
	
Chihiro   Yokota
    	
 
    	
Vincent   P. Andress
    
	
 
    	
 
    	
 
    
	
Vice   President
    	
 
    	
Assistant   Secretary
    
	
 
    	
 
    	
 
    
	
License &   Alliances
    	
 
    	
AkaRx, Inc.
    
	
 
    	
 
    	
 
    
	
Astellas   Pharma Inc.
    	
 
    	
 
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

SCHEDULE A

 

A)                       Polymorph Additional Patent Filings

 

[title of the invention]  [***]

 

[priority application] Japanese Patent Application 2011-169730, filed Aug. 3, 2011

 

[PCT application] To be filed

 

[pending country] Japan

 

[details]

 

	
Country
    	
 
    	
Filing date
    	
 
    	
Application
   Number
    	
 
    	
Publication
   Number
    	
 
    	
Patent Number
    	
 
    	
Status
    
	
Japan
    	
 
    	
3 AUG 2011
    	
 
    	
Japanese Patent Application 2011-169730
    	
 
    	
—
    	
 
    	
—
    	
 
    	
Pending
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

AMENDMENT NO.4

 

TO THE YM477 LICENSE AGREEMENT

 

This AMENDMENT NO.4 TO THE YM477 LICENSE AGREEMENT (the “Amendment”), is entered into as of this 21st day of October, 2013 (the “Amendment Effective Date”) by and between Astellas Pharma Inc., a company organized and existing under the laws of Japan and having its principal office at 5-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (“Licensor”), and AkaRx, Inc., organized and existing under the laws of Delaware and having its principal office at I 00 Tice Blvd., Woodcliff Lake, NJ, a wholly-owned subsidiary of Eisai Inc. (“Licensee”).  Licensor and Licensee are referred to collectively herein as the “Parties”.

 

Whereas, the Parties entered into YM477 License Agreement as of Augustl5, 2005, the Amendment No. 1 on March 8, 2007, Amendment No. 2 as of October 10, 2007 and Amendment No.3 as of March 12, 2012 (collectively the “License Agreement”), under which Licensee has been conducting pre-clinical and clinical development activities for the Product that are necessary to seek Regulatory Approval of the Product in those jurisdictions chosen by Licensee;

 

Whereas, Licensee wishes to receive certain consulting and advisory services as Licensee may need within the scope of Licensor Information furnished to Licensee pursuant to the provisions of Section 7.01 of the License Agreement and Licensor is willing to provide such consulting and advisory services to the extent that Licensor deems it necessary for Licensee to meet applicable regulatory requirements or facilitate the obtainment of Regulatory Approval;

 

Whereas, the Parties wish to amend the License Agreement to reflect the above;

 

Now, therefore, in consideration of the mutual covenants and promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

1. DEFINITIONS

 

Capitalized terms used but not defined in this Amendment have the meaning given them in the License Agreement.

 

2.    AMENDMENT TO AGREEMENT

 

The following paragraph shall be newly added as Section 4.04 of the License Agreement:

 

“4.04                  At the request of Licensee from time to time prior to the completion of the development activities set forth in Article 4, Licensor shall provide certain consulting and advisory services as Licensee may need within the scope of Licensor Information furnished to Licensee pursuant to the provisions of Section 7.01 (the “Services”) provided that such Services shall only be made available to Licensee if and when Licensor deems it  necessary for Licensee to meet applicable regulatory requirements or facilitate the obtainment of Regulatory Approval and Licensor and Licensee shall then have mutually agreed upon any other related conditions for such Services including the scope thereof, and provided further that, in any event Licensee shall pay Licensor [***] Japanese Yen (JPY[***]) per FTE/hour for any Services by Licensor under this Section, where such payment from Licensee to Licensor shall be made within thirty (30) days after the receipt of a relevant invoice issued by Licensor in Japanese Yen by bank wire transfer to a bank account designated in writing by Licensor.”

 

3.      SERVICES PROVIDED PRIOR TO THE EXECUTION OF THIS AMEMDMENT

 

In consideration of the consulting and advisory services which Licensor provided to Licensee prior to the execution of this Amendment, the details of which is described in Schedule A attached hereto, Licensee shall pay Licensor [***] Japanese Yen (JPY[***]), where such payment shall be made within thirty (30) days after the receipt of a relevant invoice issued by Licensor immediately after the Amendment Effective Date in Japanese Yen by bank wire transfer to a bank account designated in writing by Licensor. For the purpose of clarification, notwithstanding the amended Section 4.04 above, [***] Japanese Yen (JPY[***]) per FTE/hour is employed to calculate the aforementioned

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

payment for the consulting and advisory services provided from Licensor to Licensee prior to the execution of this  Amendment.

 

4.    FULL FORCE AND EFFECT

 

The License Agreement, as amended by this Amendment and effective as of the Amendment Effective Date, remains in full force and effect until expiration or termination of the License Agreement.

 

IN WITNESS WHEREOF, the Parties’ authorized representatives have executed this Amendment.

 

 

	
Astellas   Pharma, Inc.
    	
 
    	
AkaRx, Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/   Chihiro Yokota
    	
 
    	
/s/   Vincent P. Andrews
    
	
 
    	
 
    	
 
    
	
Chihiro   Yokota
    	
 
    	
Vincent   P. Andrews
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Corporate   Executive
    	
 
    	
Assistant   Secretary
    
	
 
    	
 
    	
 
    
	
Vice   President
    	
 
    	
AkaRx, Inc.
    
	
 
    	
 
    	
 
    
	
Licensing &   Alliances
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Astellas   Pharma Inc
    	
 
    	
 
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

	
 
    	
 
    	
Number of
   Scientists
    	
 
    	
Hours
    	
 
    	
Sub-
    
	
Services Provided
    	
 
    	
 
    	
Jan
    	
 
    	
Feb
    	
 
    	
Mar
    	
 
    	
Apr
    	
 
    	
May
    	
 
    	
Jun
    	
 
    	
Total
    
	
Advance   preparation for preclinical data review
    
	
(1) Advance   preparation for an on-site review of preclinical data on additional study   about action site of YM447, and checking and confirming quality control of   the study
    	
 
    	
3
    	
 
    	
22
    	
 
    	
18
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
40
    
	
(2) Advance   preparation for the on-site review of preclinical data, and checking and   confirming quality control of the studies reviewed at the 1st review   (Feb. 7&8), 2nd review (May 17), and 3rd review (planned but   not done on July 9)
    	
 
    	
14
    	
 
    	
91.25
    	
 
    	
45.5
    	
 
    	
11.25
    	
 
    	
98
    	
 
    	
64
    	
 
    	
58.5
    	
 
    	
368.5
    
	
Quality control   and response to Eisai’s request on additional study
    
	
(3) Quality   control of draft report prepared by Eisai on additional study about action   site ofYM477
    	
 
    	
2
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
6
    	
 
    	
2
    	
 
    	
0
    	
 
    	
8
    
	
(4) Preparation of   revised Figure 2 in additional study report YM477-2 about action site ofYM477   (this was part of the service (3) above, but was performed at different   month.)
    	
 
    	
2
    	
 
    	
0
    	
 
    	
2
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
2
    
	
Services on the   day of on-site review of preclinical l data
    
	
(5)  Answering to   Eisai’s questions about study materials (as binding hours)
    	
 
    	
5
    	
 
    	
0
    	
 
    	
9
    	
 
    	
0
    	
 
    	
0
    	
 
    	
7
    	
 
    	
0
    	
 
    	
16
    
	
(6) Consultation   about overall study materials considering future NOA filing in Japan (as binding   hours)
    	
 
    	
4
    	
 
    	
0
    	
 
    	
3
    	
 
    	
0
    	
 
    	
0
    	
 
    	
2
    	
 
    	
0
    	
 
    	
5
    
	
Post-on-site   review services
    
	
(7) Review and   confirm draft amendments prepared by Eisai for the study reports   (SK-971417,971435, 971454, 971615), which were subject of the 1st data review
    	
 
    	
1
    	
 
    	
0
    	
 
    	
0
    	
 
    	
0
    	
 
    	
9
    	
 
    	
8
    	
 
    	
0
    	
 
    	
17
    
	
(8) Connecting the   construction record of gene recombinant cells and the actual gene recombinant   cells used in the preclinical study, and quality control of the construction   of the gene
    	
 
    	
2
    	
 
    	
8
    	
 
    	
12
    	
 
    	
0
    	
 
    	
14
    	
 
    	
8
    	
 
    	
6
    	
 
    	
48
    
	
Total Hours
    	
 
    	
504.5
    
																		

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.Exhibit 10.5

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

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

 

TRANSITION SERVICES AGREEMENT

 

by and between

 

Eisai Inc.

 

and

 

AkaRx, Inc.

 

 

 

Dated as of March 30, 2016

 

	
 
    	
 
    	
 
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
ARTICLE 1
    	
DEFINITIONS
    	
1
    
	
 
    	
 
    	
 
    
	
1.1
    	
Certain Defined Terms
    	
1
    
	
 
    	
 
    	
 
    
	
1.2
    	
Additional Defined   Terms
    	
3
    
	
 
    	
 
    	
 
    
	
1.3
    	
Interpretation
    	
2
    
	
 
    	
 
    	
 
    
	
ARTICLE 2
    	
SERVICES
    	
2
    
	
 
    	
 
    	
 
    
	
2.1
    	
Provision of Services
    	
2
    
	
 
    	
 
    	
 
    
	
2.2
    	
Services Performed by   Affiliates and Third Parties
    	
2
    
	
 
    	
 
    	
 
    
	
2.3
    	
Pass-Through Agreements
    	
3
    
	
 
    	
 
    	
 
    
	
2.4
    	
Services Standard; FTEs
    	
3
    
	
 
    	
 
    	
 
    
	
2.5
    	
Ongoing Trials; Drug   Approval Applications
    	
5
    
	
 
    	
 
    	
 
    
	
2.6
    	
Assigned Contracts
    	
6
    
	
 
    	
 
    	
 
    
	
2.7
    	
Regulatory Services
    	
7
    
	
 
    	
 
    	
 
    
	
2.8
    	
Pharmacovigilance
    	
7
    
	
 
    	
 
    	
 
    
	
2.9
    	
Location of Services   Provided; Travel Expenses
    	
8
    
	
 
    	
 
    	
 
    
	
2.10
    	
Transition Management
    	
8
    
	
 
    	
 
    	
 
    
	
2.11
    	
Cooperation
    	
9
    
	
 
    	
 
    	
 
    
	
2.12
    	
Documentation
    	
9
    
	
 
    	
 
    	
 
    
	
2.13
    	
Exclusions
    	
9
    
	
 
    	
 
    	
 
    
	
2.14
    	
Exclusion of Warranties
    	
10
    
	
 
    	
 
    	
 
    
	
ARTICLE 3
    	
COMPENSATION
    	
10
    
	
 
    	
 
    	
 
    
	
3.1
    	
Services Fees
    	
10
    
	
 
    	
 
    	
 
    
	
3.2
    	
Out-of-Pocket Costs
    	
11
    
	
 
    	
 
    	
 
    
	
3.3
    	
Invoicing
    	
11
    
	
 
    	
 
    	
 
    
	
3.4
    	
Excess Costs
    	
12
    
	
 
    	
 
    	
 
    
	
3.5
    	
Due Date
    	
12
    
	
 
    	
 
    	
 
    
	
3.6
    	
Taxes
    	
13
    
	
 
    	
 
    	
 
    
	
3.7
    	
Records; Audit
    	
13
    
	
 
    	
 
    	
 
    
	
ARTICLE 4
    	
OWNERSHIP OF ASSETS:   INTELLECTUAL PROPERTY AND RIGHTS OF REFERENCE; INVENTORY
    	
14
    
	
 
    	
 
    	
 
    
	
4.1
    	
Ownership
    	
14
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

i

 

	
4.2
    	
Limited License
    	
18
    
	
 
    	
 
    	
 
    
	
4.3
    	
Inventory
    	
19
    
	
 
    	
 
    	
 
    
	
ARTICLE 5
    	
CONFIDENTIALITY
    	
20
    
	
 
    	
 
    	
 
    
	
5.1
    	
Confidentiality   Obligations
    	
20
    
	
 
    	
 
    	
 
    
	
5.2
    	
Permitted Uses and   Disclosures
    	
20
    
	
 
    	
 
    	
 
    
	
5.3
    	
Return or Destruction   of Confidential Information
    	
21
    
	
 
    	
 
    	
 
    
	
5.4
    	
Survival
    	
22
    
	
 
    	
 
    	
 
    
	
ARTICLE 6
    	
LIMITATION OF   LIABILITY; INDEMNIFICATION
    	
22
    
	
 
    	
 
    	
 
    
	
6.1
    	
Stock Purchase   Agreement
    	
22
    
	
 
    	
 
    	
 
    
	
6.2
    	
Indemnification
    	
22
    
	
 
    	
 
    	
 
    
	
6.3
    	
Limitation of Liability
    	
23
    
	
 
    	
 
    	
 
    
	
ARTICLE 7
    	
TERM AND TERMINATION
    	
23
    
	
 
    	
 
    	
 
    
	
7.1
    	
Term
    	
23
    
	
 
    	
 
    	
 
    
	
7.2
    	
Termination of Services
    	
23
    
	
 
    	
 
    	
 
    
	
7.3
    	
Asset Transfer
    	
25
    
	
 
    	
 
    	
 
    
	
7.4
    	
Accrued Rights
    	
25
    
	
 
    	
 
    	
 
    
	
7.5
    	
Surviving Obligations
    	
25
    
	
 
    	
 
    	
 
    
	
ARTICLE 8
    	
MISCELLANEOUS
    	
25
    
	
 
    	
 
    	
 
    
	
8.1
    	
Force Majeure
    	
25
    
	
 
    	
 
    	
 
    
	
8.2
    	
Independent Contractor
    	
26
    
	
 
    	
 
    	
 
    
	
8.3
    	
Assignment
    	
26
    
	
 
    	
 
    	
 
    
	
8.4
    	
No Benefit to Third   Parties
    	
26
    
	
 
    	
 
    	
 
    
	
8.5
    	
Notices
    	
26
    
	
 
    	
 
    	
 
    
	
8.6
    	
Severability
    	
27
    
	
 
    	
 
    	
 
    
	
8.7
    	
Governing Law
    	
27
    
	
 
    	
 
    	
 
    
	
8.8
    	
Jurisdiction
    	
28
    
	
 
    	
 
    	
 
    
	
8.9
    	
Service of Process
    	
28
    
	
 
    	
 
    	
 
    
	
8.10
    	
Waiver of Jury Trial
    	
28
    
	
 
    	
 
    	
 
    
	
8.11
    	
Amendments and Waivers
    	
28
    
	
 
    	
 
    	
 
    
	
8.12
    	
Joint Drafting
    	
28
    
	
 
    	
 
    	
 
    
	
8.13
    	
Obligations
    	
29
    
	
 
    	
 
    	
 
    
	
8.14
    	
Counterparts
    	
29
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

ii

 

	
8.15
    	
Entire Agreement
    	
29
    
	
 
    	
 
    	
 
    
	
8.16
    	
Dispute Resolution
    	
29
    

 

SCHEDULES

 

Schedule 2.1                         Work Order

Schedule 2.4.2                      Key Employees

 

EXHIBITS

 

Exhibit A                               Pass-Through Agreements

Exhibit B                               Form of Seller IND Transfer Letter

Exhibit C                               Form of Company IND Transfer Letter

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

iii

 

TRANSITION SERVICES AGREEMENT

 

This Transition Services Agreement (this “Agreement”) dated as of March 30, 2016 (the “Effective Date”), by and between Eisai Inc. a Delaware corporation (“Seller”), and AkaRx, Inc., a Delaware corporation (the “Company”).   Seller and the Company are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, Seller and PBM AKX Holdings, LLC, a Delaware limited liability company (“Purchaser”) are parties to that certain Stock Purchase Agreement, dated as of March 29, 2016 (the “Stock Purchase Agreement”), pursuant to which Purchaser is purchasing from Seller the Shares (as defined in the Stock Purchase Agreement);

 

WHEREAS, as the sponsor of the Ongoing Trials (as defined in the Stock Purchase Agreement), Seller has entered into the agreements listed in Exhibit A hereto relating to the conduct of the Ongoing Trials (collectively, the “Pass-Through Agreements”); and

 

WHEREAS, following the consummation of the transactions contemplated by the Stock Purchase Agreement, Seller has agreed to perform Services (defined below) for the benefit of Purchaser and the Company with respect to the Company’s operation of the Company Business (as defined in the Stock Purchase Agreement), subject to the terms and conditions contained herein which the Parties acknowledge have been negotiated on an arms’ length basis by Purchaser (on behalf of the Company) and Seller.

 

NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and set forth in the Stock Purchase Agreement and the other Ancillary Agreements (as defined in the Stock Purchase Agreement), and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:

 

ARTICLE 1
 DEFINITIONS

 

1.1          Certain Defined Terms.  Unless otherwise specifically provided herein, capitalized terms used, but not otherwise defined, in this Agreement shall have the meanings ascribed thereto in the Stock Purchase Agreement.  As used herein, the following capitalized terms have the following meanings.

 

“Accountant” means a nationally recognized independent accounting firm to be mutually agreed upon by Seller and the Company.

 

“Affiliate” means, with respect to any Person, any Person controlling, controlled by or under common control with such Person.  For purposes of this definition, “control” means, with respect to any entity, the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such entity, whether through the ownership of voting securities (or other ownership interest), by contract or otherwise.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

1

 

“Applicable Laws” means the applicable provisions of any and all Laws, Judgments, directives, and approvals of or from any Governmental Entity, as they may be in effect from time to time, including the FDCA, Drug or Health Laws, and Privacy Laws.

 

“Clinical Trial Materials” means materials used in the conduct of the Ongoing Trials or otherwise in the performance of Clinical Trial Services, including the Compound and Products packaged for use in the Ongoing Trials.

 

“Compound INDs” means Investigational New Drug Application #062122, Investigational New Drug Application #075537 and Investigational New Drug Application #076680” (collectively, the “US INDs”) and any and all other Investigational New Drug Applications or their foreign equivalents (including any clinical trial authorizations) for the Compound held by Seller or any of its Affiliates as of the Effective Date.

 

“Excluded Services” means corporate management, legal, insurance, treasury, tax, travel planning services, meeting planning services, public affairs, internal audit and all other services not specifically covered by the Work Order or any Change Order.

 

“FTE” means the equivalent of the work of one employee of Seller full time for one Calendar Year (consisting of at least a total of [***] hours per Calendar Year of work in directly providing the Services). If a Change Order contemplates that any Seller employee would devote fewer than [***] hours per year in providing the Services, such employee shall be treated as an FTE on a pro-rata basis, calculated by dividing the actual number of hours worked by such employee in providing the Services by [***].  Any employee who devotes more than [***] hours per year in providing the Services shall be treated as one (1) FTE, unless otherwise indicated in a Change Order.

 

“FTE Costs” means, with respect to any Calendar Quarter, the product of (a) the estimated total number of FTEs during such Calendar Quarter, multiplied by (b) the FTE Rate applicable to such Calendar Quarter.

 

“FTE Rate” means $[***] per Calendar Year, or $[***] per Calendar Quarter.

 

“Guarantee” means the Guarantee, dated as of the date hereof, between Seller and PBM Capital Investments LLC.

 

“Ongoing Trials Information” means all materials, documents, data (including data contained in case report forms and all pharmacovigilance data and safety database information), information, records and reports that are either (i) generated or created (including by any clinical trial site or investigator or by any Pass-Through Contractor) in the conduct of the Ongoing Trials or (ii) disclosed or learned by Seller in the conduct of the Ongoing Trials and relate solely to the Compound or the Ongoing Trials.

 

“Pass-Through Contractors” means the counterparties that have entered into the Pass-Through Agreements with Seller.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

2

 

“Person” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, Governmental Entity or other entity.

 

“Privacy Laws” means all Laws with respect to the collection, use, transfer, storage, deletion, processing (both by computer and manually), combination or other use of subject or other personal data, including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder, any comparable foreign Laws relating to the security or privacy of medical information, and any applicable state privacy Laws.

 

“Regulatory Documentation” means all (i) regulatory applications, submissions, registrations, licenses, authorizations, filings (including Drug Approval Applications) and approvals, and (ii) correspondence, notifications and reports submitted to or received from Governmental Entities (including regulatory authority meeting requests, minutes and official contact reports relating to any communications with any regulatory authority) and all supporting documents with respect thereto, in each case, ((i) and (ii)), relating to the Compound or Product.

 

“Service Period” means, with respect to any particular Service, the period between the Effective Date and the end date of such Service as set forth in the Work Order or, if applicable, any Change Order.

 

1.2          Additional Defined Terms.  For purposes of this Agreement, the following capitalized terms have the meanings set forth in the pages indicated:

 

	
Accountant,   1
    	
Debarred/Excluded, 10
    
	
Affiliate,   1
    	
Disclosing Party, 17
    
	
Aggregate   Expense Amount, 12
    	
Dispute, 26
    
	
Agreement,   1
    	
Documentation,   9
    
	
Applicable   Company Employees, 4
    	
Effective Date, 1
    
	
Applicable   Employees, 4
    	
Excluded   Services, 2
    
	
Applicable Laws, 2
    	
Extent,   2
    
	
Assigned   Contract, 6
    	
Force   Majeure Event, 22
    
	
Breaching   Party, 21
    	
FTE,   2
    
	
Budget,   2
    	
FTE Costs,   2
    
	
Change   Order, 2
    	
FTE Rate,   2
    
	
Chosen   Courts, 25
    	
Gurantee,   2
    
	
Clinical Trial Materials, 2
    	
include,   2
    
	
Clinical   Trial Service Period, 5
    	
Including,   2
    
	
Clinical   Trial Services, 5
    	
Invoice   Dispute, 12
    
	
CMC,   16
    	
Key   Employee, 4
    
	
Company,   1
    	
Notice,   23
    
	
Company   Indemnitees, 19
    	
Notice   Period, 21
    
	
Company   Inventories, 16
    	
Ongoing   Trials Information, 2
    
	
Company   Property, 14
    	
Other   Seller Costs, 11
    
	
Complaining   Party, 21
    	
Out-of-Pocket   Costs, 11
    
	
Compound INDs,   2
    	
Parties,   1
    
	
Confidential   Information, 17
    	
Party,   1
    

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

3

 

	
Pass-Through Agreements, 1
    	
Seller   Indemnitees, 19
    
	
Pass-Through   Contractors, 2
    	
Seller   Intellectual Property, 15
    
	
Payments,   13
    	
Service,   2
    
	
Permitted   Use, 18
    	
Service   Fee, 2
    
	
Person,   3
    	
Service   Period, 3
    
	
Pharmacovigilance   Agreement, 7
    	
Services,   2
    
	
Privacy Laws,   3
    	
Services   Fees, 2
    
	
Purchaser,   1
    	
Stock Purchase Agreement, 1
    
	
PV   Service Period, 7
    	
Term,   20
    
	
Receiving   Party, 17
    	
Third   Party Claims, 19
    
	
Regulatory   Documentation, 3
    	
Third   Party Materials, 15
    
	
Retention   Period, 9
    	
Transition   Managers, 8
    
	
Safety   Information, 8
    	
US INDs,   2
    
	
Seller,   1
    	
Work Order, 2
    

 

1.3          Interpretation.  All Schedules and Exhibits annexed hereto are hereby incorporated in and made a part of this Agreement as if set forth in full herein.  Any capitalized term used in the Schedules or the Exhibits but not otherwise defined therein shall have the meaning as defined in this Agreement.  References to defined terms in the singular shall include the plural and references to defined terms in the plural shall include the singular.  “Extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”.  “Including” (and, with correlative meaning, “include”) means including, without limiting the generality of any description preceding or succeeding such term, and the rule of ejusdem generis will not be applicable to limit a general statement preceded, followed by or referable to an enumeration of specific matters, to matters similar to those specifically mentioned.  The descriptive headings of the several Articles and Sections of this Agreement and the Table of Contents to this Agreement are inserted for convenience only, do not constitute a part of this Agreement and shall not affect in any way the meaning or interpretation of this Agreement.  All references herein to “Articles,” “Sections”, “Schedules” or “Exhibits” shall be deemed to be references to Articles or Sections of this Agreement or Schedules or Exhibits hereto unless otherwise indicated.  The terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement.  All accounting terms used herein and not expressly defined herein shall have the meanings given to them under GAAP.  Unless otherwise specified or where the context otherwise requires, (A) wherever used, the word “or” is used in the inclusive sense (and/or), (B) references to a Person are also to its successors and permitted assigns, (B) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto, (C) references to monetary amounts are denominated in Dollars, and (D) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

4

 

ARTICLE 2  

SERVICES

 

2.1          Provision of Services. The Parties have agreed upon the work order attached hereto and incorporated herein as Schedule 2.1 (the “Work Order”), which, as of the Effective Date, includes an estimated number of FTEs required to provide the Services, the agreed-upon FTE Costs payable for each Service (each, a “Service Fee” and collectively, the “Services Fees”), and the budget for payment of each Service Fee on a Calendar Quarter basis and the anticipated Out-of-Pocket Costs (the “Budget”) and, within ninety (90) days following the Effective Date will be revised by mutual agreement of the Parties to also describe the deliverables to be provided and the tasks and activities to be performed by Seller pursuant to this Agreement (each, a “Service” and collectively, the “Services”) and the Service Period for each Service. Any changes to the Services or the Work Order, including any modification to the Services Fees, the Budget or any Service Period, shall be made only with the written approval of both Parties and shall be detailed in a written amendment to the Work Order, which shall be deemed incorporated herein upon execution by both Parties’ Transition Managers (“Change Order”); provided, that Seller shall not unreasonably withhold consent to any Change Order, and any Services so provided under any Change Order shall be on fee terms that are consistent with the fee terms set forth in this Agreement. All Change Orders, including any increases in the Services Fees and any changes in the Budget (including increases or decreases due to acceleration of activities) must be approved by the Company in a writing signed by the Company’s Transition Manager prior to Seller commencing or accelerating any work arising from such change or charging any costs that exceed the Services Fees or Budget; provided, however, that (a) the Company shall not unreasonably withhold, condition or delay approval of any Change Order that results from circumstances not within the reasonable control of Seller or its Affiliates (including any delay or extension of the Ongoing Trials or any requirement by a Governmental Entity or Applicable Law) and (b) if the Company so unreasonably withholds, conditions or delays, or otherwise refuses to grant, consent to such Change Order, Seller shall have no obligation to provide, or cause to be provided, any work or Service that is the subject of such Change Order.   Only the Transition Managers shall be authorized to execute any Change Order.  To the extent that any terms set forth in the Work Order or any Change Order conflict with the terms of this Agreement, the terms of this Agreement shall control unless the Work Order or Change Order specifically references a provision of this Agreement and indicates that the terms of the Work Order or Change Order shall control over such provision. Any deliverables to be provided hereunder shall be provided in accordance with the acceptance criteria included in the Work Order or any Change Order or, if there are no acceptance criteria for a deliverable included in the Work Order or any Change Order, such deliverable shall be subject to the Company’s reasonable approval.

 

2.2          Services Performed by Affiliates and Third Parties.  Seller shall have the right to perform the Services either itself or through any Affiliate or through any Third Party that performs Services for the benefit of Seller or its Affiliates as of the Effective Date. Except as provided in the preceding sentence or as set forth in Section 2.3, Seller may not subcontract or delegate any of the Services to a Third Party without the Company’s prior written consent.  In the event that the Company does so consent, then any agreement entered into by Seller with the permitted Third Party subcontractor shall, to the extent reasonably practicable, name the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

5

 

Company as intended third party beneficiary of such agreement and provide for ownership and allocation of Intellectual Property rights and for obligations of confidentiality, record-keeping, and access that are consistent with the terms of this Agreement. Notwithstanding any permitted subcontracting, subject to Section 6.3, Seller shall remain liable for the performance of any obligations hereunder that it delegates to a subcontractor, and Seller hereby expressly waives any requirement that the Company exhaust any right, power or remedy, or proceed directly against such subcontractor, for any obligation or performance hereunder, prior to proceeding directly against Seller.

 

2.3          Pass-Through Agreements.  Subject to this Section 2.3, the Company hereby consents to Seller’s subcontracting and delegation to the Pass-Through Contractors of the Ongoing Trials-related services set forth in the Pass-Through Agreements. Within seven (7) Business Days after the Effective Date, Seller shall instruct each of the Pass-Through Contractors to copy the Company’s Transition Manager on all email communications with respect to all matters pertaining to the Ongoing Trials (but not with respect to Seller’s unrelated business or products) and to provide to the Company, at the same time as the Pass-Through Contractor provides to Seller, all updates, reports, documentation and other information relating to the Ongoing Trials to be provided under the Pass-Through Agreements; provided, however, that in the event the Pass-Through Contractor fails to follow such instructions with respect to any such communications, Seller shall promptly inform the Company of all such communications from such Pass-Through Contractor related to the status, cost and progress of, and other substantive matters with respect to the Ongoing Trials.  For clarity, Seller shall not have any liability for any Pass-Through Contractor’s failure to follow such instructions.  From and after the Effective Date, subject to Section 2.4.3, Seller shall continue to interact directly with the Pass-Through Contractors and shall have the authority to make ordinary course decisions with respect to all matters pertaining to the Ongoing Trials; provided, that, in the course of interacting with the Pass-Through Contractors or making decisions pertaining to the Ongoing Trials, Seller shall not take any action that (i) would cause Seller to breach any Pass-Through Agreement or to violate any Applicable Laws or (ii) is inconsistent with the Company’s reasonable directions to Seller or final decision-making authority as provided in Section 2.4.3. Subject to the foregoing, Seller shall continue to perform its obligations and comply with all of the terms applicable to Seller under the Pass-Through Agreements (except to the extent any act or omission by the Company materially inhibits or prevents Seller’s performance of such obligations) and, at the request of the Company, Seller shall enforce the provisions and obligations of the Pass-Through Contractors under each of the Pass-Through Agreements for the benefit of the Company. Seller covenants and agrees that it shall not amend, waive any right under, voluntarily terminate, or, except as set forth in this Section 2.3, take any other material action under or with respect to any of the Pass-Through Agreements as they relate to the Ongoing Trials without the Company’s prior written consent.

 

2.4          Services Standard; Applicable Employees.

 

2.4.1       The Company acknowledges that Seller is not in the business of providing services to Third Parties and is entering into this Agreement only in connection with the transactions contemplated by the Stock Purchase Agreement.  Seller shall perform the Services in accordance with the terms and conditions of this Agreement, including the Work Order, with

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

6

 

substantially the same degree of skill, quality and care utilized by Seller (or its Affiliates) in performing such activities for the Company prior to the Effective Date (subject to any requirements of Section 2.3 and this Section 2.4) and in compliance with all Applicable Laws.

 

2.4.2       Seller shall ensure that its (and its Affiliates’) employees who perform Services (the “Applicable Employees”) are properly trained and sufficiently qualified and experienced to perform the Services in accordance with this Section 2.4.  Without limiting the foregoing, unless the Company agrees otherwise in writing (such agreement not to be unreasonably withheld, conditioned or delayed), Seller shall utilize in the performance of the Services the same employees utilized by Seller in performing such activities for the Company prior to the Effective Date, or employees of Seller who have substantially equivalent training, qualifications and experience as such employees, provided, that in each case such employees (including those utilized to perform activities for the Company prior to the Effective Date) meet the standards set forth in this Section 2.4.  Notwithstanding the foregoing, subject to resignations or terminations in accordance with Seller’s policies, Seller shall utilize each of the Applicable Employees listed in Schedule 2.4.2 (each a “Key Employee”) to perform the same Services as such Key Employee provided for the Company prior to the Effective Date, and Seller shall not diminish or alter (through transfer, reassignment or otherwise) the scope of any Services or any obligations with respect to the Services performed by any Key Employee prior to completion of the applicable Services and expiration of the Service Period applicable to the Services assigned to such Key Employee, without the prior written consent of the Company.  Seller shall notify the Company (through the Transition Managers) if any Key Employee provides notice of resignation to or is terminated by Seller in accordance with Seller’s policies.

 

2.4.3       Notwithstanding anything to the contrary herein, the Company shall have the authority to reasonably direct the Applicable Employees in the manner of performing the Services and shall have final decision-making authority with respect to matters that, in the Company’s sole judgment, would be expected to materially affect the Ongoing Trials or the time to completion thereof or materially affect the cost of completing the Ongoing Trials.  All of the Company’s directions to Applicable Employees shall be made through Seller’s Transition Manager or the Key Employees.  Seller’s Transition Manager and Key Employees shall have the responsibility within Seller’s organization for interacting directly with the other Applicable Employees and shall have the authority to cause such other Applicable Employees to carry out the Company’s reasonable directions.  Seller shall instruct the Applicable Employees to, and shall take reasonable actions to ensure that the Applicable Employees shall, (a) comply with all reasonable directions relating to the Services given by the Company (and communicated through Seller’s Transition Manager and the Key Employees) and (b) respond promptly to the Company’s reasonable inquiries relating to the Services.  The Company shall instruct its employees with responsibility for carrying out the Company’s rights and duties under this Agreement or otherwise with respect to the Ongoing Trials (the “Applicable Company Employees”) to, and shall take reasonable actions to ensure that such employees shall respond promptly to Seller’s reasonable inquiries relating to the Services.  In the event that either Party (the “Notifying Party”) reasonably believes that the Applicable Employees or the Applicable Company Employees, as applicable, are failing to promptly respond to such inquiries or that the Applicable Employees are failing to comply with all reasonable directions relating to the performance of the Services given by the Company in accordance with this Section 2.4.3, the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

7

 

Notifying Party’s Transition Manager shall notify the other Party’s Transition Manager of such unresponsiveness and the Transition Managers shall discuss and work together in good faith to resolve any impact such failure may have to the provision of the Services.  In the event such failures to promptly respond or to comply with reasonable directions are not resolved within ten (10) Business Days after the Notifying Party’s Transition Manager provides notice of such failure(s) to the other Party’s Transition Manager, or if any such failure that is successfully resolved by the Transition Managers recurs two (2) or more times in the three (3) month period following such resolution, such failure(s) shall be deemed to be a material breach of this Agreement.

 

2.4.4       Each Party acknowledges and agrees that the Applicable Employees are not, and are not intended to be or be treated as, employees of the Company or any of its Affiliates, and that such individuals are not, and are not intended to be, eligible to participate in any benefits programs or in any “employee benefit plan,” as such term is defined in Section 3(3) of ERISA, that may be sponsored by the Company or any of its Affiliates or that may be offered from time to time by the Company or its Affiliates to its or their own employees. Except as expressly set forth in this Agreement, from and after the Effective Date, Seller’s and the Company’s respective obligations and rights with respect to the Company Business shall be as set forth in the Stock Purchase Agreement and any applicable other Ancillary Agreements.  For the avoidance of doubt, the Services do not include, and Seller shall have no obligation to provide, any of the Excluded Services; provided that, for clarity, Seller shall provide oversight and management incidental to the Services.

 

2.4.5       Seller shall perform its obligations and comply with all of the terms applicable to Seller under all of its agreements with Third Parties that perform Services for the benefit of Seller or its Affiliates as of the Effective Date and with any other permitted Third Party subcontractors (except to the extent any act or omission by the Company prevents Seller’s performance of such obligations).

 

2.5          Ongoing Trials; Drug Approval Applications.

 

2.5.1       As set forth in the Work Order, Seller shall oversee and manage the Ongoing Trials, including the services and activities of the Pass-Through Contractors under the Pass-Through Agreements, subject to Section 2.3 and the control and direction of the Company as set forth in this Agreement. Seller shall hold and maintain the Compound INDs and continue as the sponsor of the Ongoing Trials during the Service Period for the Services set forth in the Work Order relating to the Ongoing Trials (such Services, the “Clinical Trial Services” and such period, as the same may be modified in a Change Order or terminated by the Company pursuant to Section 7.2.1, the “Clinical Trial Service Period”). As sponsor of the Ongoing Trials, Seller shall comply with all Applicable Laws, including regulations applicable to sponsors under 21 CFR 312. Seller and the Company shall, and shall cause their respective Affiliates to, file all documents required to be filed with each applicable Governmental Entity and take all other actions as reasonably may be required to effectuate the transfer of the Compound INDs from Seller to the Company in the Territory in accordance with Applicable Laws as soon as reasonably practicable after the Clinical Trial Service Period or such earlier time as may be requested in writing by the Company (to the extent not prohibited by Applicable Law or the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

8

 

applicable Governmental Entity).  Subject to the foregoing, Seller shall file with FDA the transfer letters in the form of Exhibit B transferring to the Company the US INDs and the Company shall file with FDA the transfer letters in the form of Exhibit C accepting the transfer of the US INDs, in each case, within five (5) Business Days following the end of the Clinical Trial Service Period or such earlier time as may be requested in writing by the Company; provided, that, as between the Parties, nothing in such transfer letters filed by Seller or the Company shall affect the rights or obligations of the Parties hereunder.  Transfer of title to each of the Compound INDs in the Territory from Seller to the Company shall be effective as of the end of the Clinical Trial Service Period or such earlier time as may be requested in writing by the Company.  All Drug Approval Applications (other than the Compound INDs) shall be filed under the Company’s name and the Company may designate Seller as its agent if the Company deems it necessary or useful for Seller, in the course of performing the Services, to respond to inquiries from Governmental Entities with respect to such filings.  Seller shall not have any obligations with respect to post-approval obligations imposed by relevant Governmental Entities in connection with the grant of any Drug Approval Application.

 

2.5.2       After transfer of the US INDs to the Company, the Company commits to (a) complying with the reporting requirements for important safety information: reporting any unexpected fatal or life-threatening adverse events associated with the use of the Compound or any Product by telephone or fax no later than seven (7) days after initial receipt of the information; and reporting any adverse experiences associated with the use of the Compound or any Product that is both serious and unexpected no later than fifteen (15) days after initial receipt of the information; and submitting annual reports within sixty (60) days of each anniversary of the date on which each US IND went into effect, (b) continue the agreements, promises, and conditions made by Seller to FDA and contained in the application with respect to each US IND, and (c) notify FDA of any changes made to any US IND in accordance with the new principles and requirements identified under 21 CFR 312 as clinical trials continue.

 

2.6          Assigned Contracts.  Prior to or promptly following the Clinical Trial Service Period (with respect to Contracts pertaining to the Clinical Trial Services) and at any time during the Term (with respect to other Contracts), the Parties will agree on which Contracts, if any, need to be assigned by Seller to the Company (collectively, the “Assigned Contracts”).  As promptly as practicable thereafter, subject to the receipt of all necessary Consents of Third Parties, Seller shall assign, transfer, convey and deliver to the Company each of the Assigned Contracts.  In the event the Consent of a Third Party is required in order to so assign, transfer, convey or deliver an Assigned Contract, Seller shall use commercially reasonable efforts to obtain such Consent for a period of six (6) months following the date on which the Parties agree to assign the applicable Assigned Contract, provided, that Seller shall have no obligation to (a) make any payments to any Third Party or incur any obligations in respect of any such Consent which payments are not subject to reimbursement by the Company or which obligations are not assumed by the Company hereunder, or (b) enter into any alternative arrangements that are not commercially reasonable or that are not subject to reimbursement by the Company hereunder, in either case, in the event that any such Consent is not obtained.  In the event Seller is unable to obtain the necessary Consent to assign any Assigned Contract, Seller shall continue to enforce such Assigned Contract for the benefit of the Company for the six (6) month period following the date on which the Parties agree to assign the applicable Assigned Contract or if longer, for so long as any ongoing

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

9

 

obligations of the Third Party under such Assigned Contract (such as confidentiality obligations) remain in effect (provided that the Company pays or otherwise performs any corresponding obligation under any such Assigned Contract).  The Company shall reasonably cooperate with Seller in its efforts to obtain any Third Party Consents contemplated by this Section 2.6.

 

2.7          Regulatory Services.

 

2.7.1       In the event Seller, in the course of performing the Services, is required to submit any Regulatory Documentation to a Governmental Entity, Seller shall provide the Company a draft of such Regulatory Documentation as far in advance of the intended date of submission as reasonably possible and shall incorporate any comments thereto provided by the Company.  Seller shall promptly notify the Company of any other Regulatory Documentation received from or to be submitted to any Governmental Entity, including correspondence, meeting minutes and summaries received by Seller from, or to be submitted by Seller to, any Governmental Entities, and shall provide the Company with copies thereof within five (5) Business Days after receipt thereof or, if such documents are prepared by Seller for submission to Governmental Entities, sufficiently in advance of such submission so as to allow the Company to review and finalize the content of such submission with Seller. Notwithstanding the foregoing, Seller shall not be required to delay a regulatory submission to any Governmental Entity or incorporate any comments of the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws.  For clarity, the terms of this Section 2.7.1 do not apply to correspondence with or reporting to Governmental Entities regarding adverse events or other safety information pertaining to the Compound or Products, which correspondence and reporting are governed by the terms of Section 2.8.

 

2.7.2       Seller shall provide the Company with reasonable advance notice of all meetings, conferences and discussions scheduled with any Governmental Entity concerning the Compound or Product, and shall incorporate any input from the Company in preparing for such meetings, conferences or discussions; provided, that Seller shall not be required to incorporate any input from the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws.  One or more representatives of the Company shall have the right to attend and participate in all such meetings, conferences, and discussions to the extent not prohibited by Applicable Law or the applicable Governmental Entity, and Seller shall facilitate such participation.  If the Company elects not to participate in such meetings, conferences or discussions, Seller shall provide the Company with written summaries of such meetings, conferences or discussions as soon as reasonably practicable after the conclusion thereof.

 

2.8          Pharmacovigilance.  Until the end of the Service Period set forth in item 8 in the Work Order (such period, as the same may be modified in a Change Order or terminated by the Company pursuant to Section 7.2.1, the “PV Service Period”), Seller shall bear responsibility for pharmacovigilance relating to the Compound and Products, including for the timely reporting of all adverse drug reactions/experiences and aggregate safety data relating to the Compound. As part of the Services, Seller shall communicate with the Company regarding Product pharmacovigilance matters and, in furtherance thereof, the Parties shall enter into a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

10

 

information exchange to be carried out by the Parties (the “Pharmacovigilance Agreement”).  The Pharmacovigilance Agreement shall contain guidelines and procedures for the receipt, investigation, recording, communication, and exchange of reports of adverse drug reactions/experiences, safety data and other information concerning the safety of Product or the Compound (“Safety Information”), and shall in all events include such terms as are necessary to ensure that the Parties comply with Applicable Laws and meet the reporting requirements of any applicable Governmental Entity.  Without limiting the foregoing, prior to execution of the Pharmacovigilance Agreement, Seller shall instruct Quintiles, Inc. to copy the Company’s Transition Manager on all communications transmitting Safety Information to Seller, and in the event Seller receives any Safety Information that meets the criteria for a Serious, Suspected Adverse Drug Reaction (as defined in ICH E2A) in a communication to which the Company is not copied, Seller shall send the source documents including such Safety Information that were transmitted by Quintiles, Inc. to the Company, or other mutually agreed format, via email or fax as soon as possible, but, in any event, not later than One (1) Business Day after Seller receives such Safety Information, and, in the event Seller receives any information concerning any investigation, inquiry or other action by any Governmental Entity concerning the safety of the Compound or Product, Seller shall send such information to the Company via email or fax as soon as possible, but in any event, no later than two (2) days after Seller receives notice of such investigation, inquiry or other action. As soon as reasonably practicable after the PV Service Period or such earlier time as may be requested in writing by the Company, Seller shall take all actions as reasonably may be required to effectuate the transfer to the Company of all Safety Information, including the portion of Seller’s global safety database that pertains to the Compound and the Products.

 

2.9          Location of Services Provided; Travel Expenses.  Seller shall provide the Services to the Company, as applicable, from locations of Seller’s choice in its sole discretion unless Services are required to be performed at a specific location identified in the Work Order.  Should the provision of Services require any personnel of Seller to travel beyond 50 miles from his or her employment location, the Company shall reimburse Seller for all reasonable travel-related costs, consistent with Seller’s travel policy, which costs shall be deemed Other Seller Costs and shall be reimbursed in accordance with Section 3.2; provided, however, that the Company shall have no obligation to reimburse Seller for such travel-related costs unless such travel is pre-approved by the Company and any expenses in excess of $1,000 associated with such travel are pre-approved by the Company.

 

2.10        Transition Management .  Within five (5) Business Days after the Effective Date, the Company and Seller each shall designate an appropriate point of contact for all questions and issues relating to the Services (the “Transition Managers”).  Each of Seller and the Company may, by written notice given to the other such Party, replace its Transition Manager.  The Transition Managers shall meet at least twice per month, or on such other schedule as mutually agreed upon by Seller and the Company, during the Term in person or telephonically in order to discuss the status of the Services and to manage any open issues relating to the Services.  In addition, if and as reasonably requested by the Company, the Transition Managers will establish transition teams composed of representatives from each Party who have the requisite experience and authority to enable such representatives to monitor, coordinate and make decisions on behalf of the Parties with respect to the Services (or any particular Service).

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

11

 

2.11        Cooperation.  Each of the Company and Seller shall use commercially reasonable efforts to cooperate with one another in all matters relating to the provision and receipt of the Services.  Without limiting the generality of the foregoing sentence, the Company shall permit Seller, its Affiliates and its and their employees and agents reasonable access, upon reasonable notice during regular business hours, to such personnel of the Company as are involved in receiving or overseeing the Services, and data and records of the Company as reasonably requested by Seller to facilitate Seller’s performance under this Agreement. Seller shall be excused from performing any obligation under this Agreement to the extent the Company’s failure to perform its obligations under this Agreement prevents Seller’s performance of such obligation, including to the extent any Service is dependent on the Company timely providing to Seller or any of its Affiliates information, materials, products and like items in a manner substantially similar in nature, quality and timeliness to the information, materials, products and like items provided by the Company to Seller and its Affiliates at the time of the Closing and the Company fails to so provide such information, materials, products and like items; provided, however, in the event that the Company fails to provide such information, materials, products and like items, the Transition Manager of Seller shall provide notice of such failure to the Transition Manager of the Company and the Transition Managers shall discuss and work together in good faith to resolve any impact such failure may have to the provision of the Services.  Upon the Company’s request, Seller shall reasonably cooperate with the Company to renegotiate the terms of any existing agreement with a Third Party contractor that is required for Seller to provide any Services in order to reduce (to the extent reasonably possible) the amounts paid by Seller to such Third Party contractor in connection with the Services.  The Company shall reimburse Seller for all actual, reasonably incurred, documented, out-of-pocket costs and expenses incurred by Seller or its Affiliates in connection with such cooperation, which costs and expenses shall be deemed Other Seller Costs and shall be reimbursed in accordance with Section 3.2.

 

2.12        Documentation.  As part of the Services, Seller shall create and keep (and shall cause its Affiliates and permitted subcontractors to create and keep) accurate records, notes, reports, writings and other documentation reflecting all work done and results achieved in performance of the Services (collectively, “Documentation”), in tangible or electronic form, in a timely, accurate, complete and legible manner.  Seller shall (and shall cause its Affiliates and permitted subcontractors to) maintain the Documentation during the Term and for the longest of (a) five (5) years after expiration or termination of this Agreement, (b) two (2) years after FDA approval of the New Drug Application for the Product, or (c) the retention period required by Applicable Laws, if any (“Retention Period”).  During the Retention Period, upon reasonable advanced notice during regular business hours, Seller shall make the Documentation available for inspection and copying by the Company, at the Company’s sole cost and expense.  After the Retention Period, Seller shall provide the Company at least sixty (60) days’ written notice before destroying any Documentation and, if requested by the Company, Seller shall transfer the Documentation to the Company or its designee at the Company’s expense.

 

2.13        Exclusions.  Notwithstanding anything herein to the contrary, in no event shall Seller or any of its Affiliates be (a) obligated to provide any Services that would be unlawful for Seller to provide or that would require Seller to violate Applicable Law; (b) obligated to hire any additional employees to perform the Services or maintain the employment of any specific

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

12

 

employee, except as set forth in Section 2.4.2 and, if applicable, the Work Order; (d) subject to Section 2.4, obligated to hire replacements for employees that resign, retire or are terminated; (e) obligated to enter into retention agreements with employees or otherwise provide any incentive beyond payment of regular salary and benefits; (f) subject to Section 2.4, prevented from transferring after the Effective Date any employees (other than Key Employees) who were supporting the Company Business as of the Effective Date to support other businesses of Seller or its Affiliates or to assume other roles with Seller or its Affiliates to the extent such employees are not required to provide Services; or (g) subject to Section 2.4, prevented from determining, in its sole discretion, the individual employees (other than Key Employees) who will provide Services.

 

2.14        Seller’s Representations, Warranties and Covenants.  Seller hereby represents, warrants and covenants to the Company as follows:

 

(a)           except to the extent such performance is expressly excused by this Agreement, it shall perform the Services in compliance with the Work Order, all Applicable Laws and the standards set forth in Section 2.4; and

 

(b)           neither it, nor any of its Affiliates, nor to Seller’s Knowledge, any of their respective officers, employees, agents, representatives, subcontractors or other persons used in the performance of its obligations under this Agreement has been debarred or suspended under 21 U.S.C. §335(a) or (b), excluded from a federal health care program, debarred from federal contracting, or convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud (“Debarred/Excluded”). Seller shall promptly notify the Company if Seller becomes aware that it, any of its Affiliates, or any officer, employee, agent, representative, subcontractor or other Person who is performing any activities under this Agreement is or becomes Debarred/Excluded or receives notice of action or threat of action to be Debarred/Excluded.  In the event that Seller, any of Seller’s Affiliates or any officer or employee of Seller or any of its Affiliates who is performing any activities under this Agreement is or becomes Debarred/Excluded or receives notice of action or threat of action to be Debarred/Excluded, the Company shall have the right to terminate this Agreement.  In the event that any other Person who is performing any activities under this Agreement on behalf of Seller is or becomes Debarred/Excluded or receives notice of action or threat of action to be Debarred/Excluded, upon notice from the Company, Seller shall promptly terminate the agreement under which such activities are provided.

 

2.15        Exclusion of Warranties.  EXCEPT AS PROVIDED IN THIS AGREEMENT OR THE STOCK PURCHASE AGREEMENT, NEITHER SELLER NOR ANY OF ITS AFFILIATES MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE SERVICES.

 

ARTICLE 3

COMPENSATION

 

3.1          Services Fees. In consideration for the performance of the Services by Seller, the Company shall pay the Services Fees with respect to the applicable Services in accordance with

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

13

 

the Budget. The Company shall not be obligated to pay to Seller (a) for any Service, any amount in excess of the Service Fee amount set forth in the Budget for performance of such Service or (b) Services Fees that exceed, in the aggregate, $8,540,000, unless, in each case ((a) and (b)), the Company consents to do so in writing.

 

3.2          Out-of-Pocket Costs.  In addition to the Services Fees, the Company shall reimburse Seller for (a) all amounts paid by Seller to the Pass-Through Contractors for performance of Ongoing Trials-related services under the Pass-Through Agreements, (b) those out-of-pocket costs and expenses described in the Budget or any Change Order; (c) except as provided in clauses (d) through (g) immediately below, any other actual, reasonably incurred, documented, out-of-pocket costs and expenses paid by Seller or its Affiliates to Third Party contractors in order to perform the Services; ((a) through (c), collectively, “Out-of-Pocket Costs”); (d) fees associated with securing any Consents required from Third Party contractors pursuant to Section 2.6; (e) actual, reasonably incurred, documented, out-of-pocket costs or expenses incurred by Seller, its Affiliates or subcontractors for the extraction, conversion and transfer of data required to be provided to the Company under this Agreement (to the extent not included in the Services); (f) actual, reasonably incurred, documented, out-of-pocket costs or expenses incurred by Seller or its Affiliates in connection with the delivery or destruction of Clinical Trial Materials pursuant to Section 4.3; (g) Seller’s and its Affiliates’ actual, reasonably incurred, documented, out-of-pocket costs and expenses for the transfer and delivery to the Company of the tangible TSA Assets and Company Property contemplated by Section 7.3; (h) Seller’s and its Affiliates’ actual, reasonably incurred, documented, out-of-pocket costs and expenses contemplated by Section 2.11; and (i) all reasonable travel-related costs contemplated by and subject to Section 2.9 ((d) through (i), collectively, “Other Seller Costs”); provided, that Seller provides the Company with reasonably detailed documentation identifying such Out-of-Pocket Costs and Other Seller Costs and, upon the Company’s request, provides the Company with receipts and other reasonable supporting documentation.  Except to the extent a lower threshold is provided for in this Agreement, to the extent any Out-of-Pocket Costs (other than as described in clause (a) immediately above) or Other Seller Costs are not included in the Budget or any Change Order, Seller shall not incur any such costs in excess of $[***] and the Company shall have no obligation to reimburse any such costs in excess of $[***], unless approved in advance in writing by the Company.  In addition, Seller shall allow the Company to participate in discussions with Seller and any Third Party regarding any agreement or other arrangement to pay Out-of-Pocket Costs (other than as described in clause (a) immediately above) or Other Seller Costs (that, in either case, are not included in the Budget or any Change Order) in excess of $[***]. Out-of-Pocket Costs and Other Seller Costs shall be reimbursed at actual cost without markup and, notwithstanding anything herein to the contrary, shall not include any late fees or other penalties incurred by Seller in connection therewith except to the extent caused by the Company.  The Company reserves the right to decline to pay unsupported or unexplained costs or expenses and, except as provided in this Section, any costs or expenses not included in the Budget or any Change Order.

 

3.3          Invoicing.  Seller shall, on a Calendar Quarter basis, invoice the Company for applicable Services Fees, Out-of-Pocket Costs and Other Seller Costs.  To the extent applicable, Services Fees will be prorated for any partial Calendar Quarter based on the actual number of

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

14

 

days in such Calendar Quarter for which Seller was providing the applicable Services relative to the total number of days in such Calendar Quarter.  All Services Fees shall be billed in arrears.

 

3.4          Excess Costs.  If the aggregate amount of Services Fees and Out-of-Pocket Costs actually paid or reimbursed by the Company to Seller in cash hereunder (including through payment of the principal amount of the Note) exceeds $51,040,000 (the “Aggregate Expense Amount”), Purchaser shall be entitled to deduct such excess amounts from the Milestone Payments payable by the Company under Section 1.02(a) of the Stock Purchase Agreement in accordance with the terms and conditions of such section.

 

3.5          Due Date.

 

3.5.1       The Company shall pay the undisputed portion of each invoice for Other Seller Costs promptly, but in no event later than forty-five (45) days, after the date of receipt of such invoice and acceptance of any deliverables to be provided.  Upon delivery of each invoice to the Company for Services Fees and Out-of-Pocket Costs, the principal amount of the Note shall automatically be increased by the aggregate amount of Services Fees and Out-of-Pocket-Costs reflected in such invoice (less any Services Fees or Out-of-Pocket Costs covered by such invoice that are paid by the Company in cash); provided, however, that if prior to the date of such invoice (a) PBM Capital Investments LLC fails to perform any of its obligations under Section 6 of the Guarantee or has breached any representation or warranty in Section 5.5 of the Guarantee or (b) the Company’s Obligations (as defined in the Note) have been accelerated, in each case ((a) and (b)), the Company shall pay the undisputed aggregate amount of Services Fees and Out-of-Pocket Costs reflected in such invoice in cash promptly, but in no event later than forty-five (45) days, after the date of receipt of such invoice and acceptance of any deliverables to be provided.  If there is any dispute concerning any portion of an invoice for Services Fees, Out-of-Pocket Costs or Other Seller Costs (an “Invoice Dispute”) that is not resolved by the Parties within thirty (30) days after the date of such invoice, such Invoice Dispute shall be referred for decision to the Accountant.  The decision of the Accountant shall be in writing and, except for manifest error on the face of the decision, shall be binding on both Seller and the Company.  The Company shall bear and pay 100% of the cost of the Accountant unless the Accountant determines all matters in such Invoice Dispute in favor of the Company, in which case Seller shall bear and pay 100% of the cost of the Accountant.  Any amount payable by the Company or Seller based on the Accountant’s decision shall be (i) to the extent related to the Other Seller Costs or to any Service Fees or Out-of-Pocket Costs payable in cash in accordance with this Section 3.5.1, paid within fourteen (14) days after the date of such decision or (ii) to the extent related to the Services Fees or the Out-of-Pocket Costs (unless payable in cash in accordance with this Section 3.5.1), added to or deducted from, as applicable, the principal amount of the Note, in each case, ((a) and (b)), in accordance with this Section 3.5.1; provided, that to the extent any Services Fees or Out-of-Pocket Costs are deducted from the principal amount of the Note in accordance with clause (b), such deduction shall be made retroactive to the date of the invoice that was the subject of the Invoice Dispute, and any interest accruing from such date shall also be eliminated.  Each Party shall reasonably cooperate with the Accountant in connection with the resolution of any Invoice Dispute.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

15

 

3.5.2       Any payments under this Agreement that are not made on or before the applicable due date shall bear interest at the rate of the Prime Rate, as reported in the print edition of The Wall Street Journal, Eastern Edition, plus two percent (2%), on the payment due date or, if unavailable, on the latest date prior to the payment due date on which such rate is available, or the maximum rate allowed by Law, whichever is less, calculated on a daily basis, based on the actual number of days elapsed from the payment due date to the date of actual payment.

 

3.6          Taxes.  The Company shall be responsible for all Taxes, if any, imposed in connection with this Agreement or the performance of Services, including any value added taxes, sales taxes, consumption taxes and other similar Taxes on the provision or receipt of the Services hereunder, exclusive of Taxes on Seller’s income.  If Seller or any of its Affiliates are required to pay such Taxes applicable to the Services, the Company shall promptly reimburse Seller therefor.  For the avoidance of doubt, the requirements of this Section 3.6 shall not apply to any employment-related taxes, income taxes or withholding and shall only apply to Taxes applicable to the Services.  The amounts payable by the Company to Seller pursuant to this Agreement (“Payments”) shall not be reduced on account of any Taxes unless required by applicable Law.  Seller alone shall be responsible for paying any and all Taxes (other than withholding Taxes required to be paid by Purchaser) levied on account of, or measured in whole or in part by reference to, any Payments it receives. The Company shall deduct or withhold from the Payments any Taxes that it is required by Applicable Law to deduct or withhold; provided, however, if Seller is entitled under any applicable Tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding Tax, it shall deliver to the Company or the appropriate Governmental Entity (with the assistance of the Company to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve the Company of its obligation to withhold Tax, and the Company shall apply the reduced rate of withholding, or dispense with the withholding, as the case may be, to the extent it complies with the applicable Tax treaty.  If, in accordance with the foregoing, the Company withholds any amount, it shall make timely payment to the proper Taxing Authority of the withheld amount, and send to Seller proof of such payment within sixty (60) days following that payment.  The Company shall not change its domicile to a jurisdiction outside of the United States or assign this Agreement to any Person that is domiciled outside of the United States.

 

3.7          Records; Audit.

 

3.7.1       Each Party shall keep and maintain, and shall cause its Affiliates to keep and maintain, complete and accurate records and books of account documenting all expenses and all other data necessary for the calculation of the amounts payable to any other Party under this Agreement consistent with its standard procedures and policies in the ordinary course of business for a period of five (5) years after such expenses are incurred or, if longer, any retention period required by Applicable Law.

 

3.7.2       Upon either Seller’s or the Company’s request, the other such Party shall, and shall cause each of its Affiliates engaged in the performance of activities under this Agreement to, permit the requesting Party and its Representatives to inspect and audit the

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

16

 

records and books of account maintained by it pursuant to Section 3.7.1 in order to confirm the accuracy and completeness of such records and books of account and all payments hereunder; provided, that no Party shall be entitled to exercise its inspection and audit rights under this Section 3.7.2 more than once per Calendar Year, unless, in any case, any prior audit resulted in an adjustment to amounts due hereunder.  The Party requesting the audit shall bear all out-of-pocket costs and expenses incurred in connection with any inspection or audit performed pursuant to this Section 3.7.2; provided, however, that the audited Party shall reimburse the Party requesting the audit for all reasonable costs and expenses incurred by such Party in connection with such inspection or audit if any such audit identifies an underpayment to the auditing Party or an overpayment to the audited Party hereunder in excess of 10% of the amounts actually payable.  In any case, the full amount of the underpayment or overpayment as applicable shall be payable to the applicable Party plus accrued interest at the rate set forth in Section 3.5.2.  All information disclosed pursuant to this Section 3.7.2 shall be subject to the non-disclosure and non-use provisions set forth in Article 5.

 

ARTICLE 4

OWNERSHIP OF ASSETS: INTELLECTUAL PROPERTY AND RIGHTS OF REFERENCE; INVENTORY

 

4.1          Ownership.

 

4.1.1       This Agreement and the performance of the Services hereunder shall not affect the ownership of any Intellectual Property rights or other assets as set forth in the Stock Purchase Agreement. For the avoidance of doubt, upon the Closing, Seller shall not retain title to, or ownership rights in, the Company or any Owned Intellectual Property or other assets of the Company, other than the TSA Assets, the Prohibited Registered IP, the Seller Manufacturing Technology, the Trademarks and certain domain names included in the Registered IP (which, for the avoidance of doubt, shall be licensed and subsequently transferred to the Company in accordance with Section 5.10(b), Section 5.10(c), Section 5.10(f) and Section 5.10(g) of the Stock Purchase Agreement, as applicable).

 

4.1.2       Except for any Seller Intellectual Property and any Third Party Materials, any and all results, products, deliverables (interim or final), reports, data (including raw data, processed data and data summaries), analyses (including analyses of data), inventions, ideas, improvements, documents (including CMC documents), discoveries, designs, drawings, protocols, processes, techniques, formulae, trade secrets, materials, methods, procedures, information, know-how, technology and other Intellectual Property that arise out of, or result from or are derived from, any of the Services or the Ongoing Trials, or that solely relate to the Compound or Products, including Ongoing Trials Information and Documentation but excluding Seller Manufacturing Technology (collectively, “Company Property”) shall be the sole and exclusive property of Company and shall be deemed the Confidential Information of the Company and subject to the confidentiality and non-use provisions of Article 5. Seller shall fully disclose to the Company any and all Company Property, whether conceived, reduced to practice, created, developed, derived, generated or otherwise obtained by Seller or its Affiliates or its or their employees, agents, consultants, subcontractors (including the Pass-Through Contractors) or other representatives, alone or jointly with others, promptly upon obtaining or becoming aware

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

17

 

of the development, creation, generation, conception or reduction to practice of such Company Property. To the extent any Company Property does not constitute Company Intellectual Property or TSA Assets (which are assigned or licensed to the Company pursuant to the Stock Purchase Agreement), Seller hereby assigns, and shall cause its Affiliates and its and their employees and subcontractors to assign, to Company all rights, title and interest in, to such Company Property.  Seller will, at the Company’s request and expense, perform any and all acts necessary to assist the Company in preparing, filing any patent applications and enforcing any patents covering such Company Property, or in otherwise perfecting its rights thereto, without further compensation other than reimbursement of Seller’s reasonable, documented out-of-pocket costs directly and solely relating thereto.

 

4.1.3       Notwithstanding the foregoing, the Company acknowledges and agrees that Seller and its Affiliates own and will retain all right, title and interest in and to inventions, ideas, improvements, documents (including CMC documents), discoveries, designs, drawings, protocols, processes, techniques, formulae, trade secrets, materials, methods, procedures, information, know-how, technology and other Intellectual Property (including Seller Manufacturing Technology) that have been or will be developed by Seller or its Affiliates outside the scope of this Agreement, but excluding Owned Intellectual Property and Product-Specific Manufacturing Technology (collectively, “Seller Intellectual Property”). Seller Intellectual Property shall also include all materials, documents, data (including data contained in case report forms and all pharmacovigilance data and safety database information), information, records and reports that are generated, created, disclosed or learned by Seller in the conduct of the Ongoing Trials to the extent such items are not included in the Ongoing Trials Information or are otherwise not included in the Company Property.  Seller shall not, without the Company’s prior written consent, incorporate or integrate any Seller Intellectual Property into any deliverables or other Company Property except as required to perform the Services.  Furthermore, Seller shall not, without the Company’s prior written consent, knowingly incorporate or integrate any materials, technology or Intellectual Property of any Third Party (“Third Party Materials”) into any deliverables or other Company Property unless, prior to incorporating such Third Party Materials, Seller shall have obtained from such Third Party any and all rights necessary to enable Seller to perform its obligations under this Agreement, including the granting of the rights as provided in the next sentence. To the extent that Seller incorporates or integrates Seller Intellectual Property or Third Party Materials into Company Property, in order to provide Company freedom-to-operate with respect to Company Property, Seller hereby grants to the Company a perpetual, assignable, sublicensable through multiple tiers, non-exclusive, worldwide, royalty-free, fully paid-up, irrevocable license under the Seller Intellectual Property and under Seller’s rights, title and interest in and to the Third Party Materials (to the extent permitted under any agreement between Seller or any of its Affiliates and the applicable Third Party) to use, make, have made, sell, offer for sale, import, reproduce, prepare derivative works of, display, distribute, disclose or publish Company Property and to Exploit the Compound, Products and otherwise conduct the Company Business.

 

4.2          Limited License.  Solely for and with respect to performance of Services and other activities and obligations under this Agreement during the Term, the Company (on behalf of itself and its Affiliates) hereby grants to Seller and its Affiliates a non-exclusive, royalty-free, fully-paid up, worldwide, non-transferable, sublicensable (without the consent of the Company

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

18

 

to any Third Party that performs Services for the benefit of Seller or its Affiliates as of the Effective Date for the purpose of continuing the performance of such Services and otherwise with the prior written consent of the Company), license and right of reference to all Company Intellectual Property, Company Property and all Drug Approval Applications owned by the Company (if any during the Term), necessary or useful to perform the Services hereunder.

 

4.3          Inventory.  The Company shall make available to Seller, its Affiliates and Seller’s and its Affiliates’ respective subcontractors and agents, and hereby grants to each of them the right to use, store, import, export, transport, distribute and dispose of, free of charge, all inventories of the Compound and Products owned by the Company as of the Effective Date or at any time during the Clinical Trial Service Period (“Company Inventories”), solely for the purpose of providing the Clinical Trial Services.  Title to, and risk of loss with respect to, the Company Inventories shall remain with the Company.  Except as provided in the first sentence of this Section 4.3, during the Clinical Trial Service Period, Seller shall be responsible for supplying Clinical Trial Materials in connection with the provision of the Clinical Trial Services; provided that if the inventories of Clinical Trial Materials as of the Effective Date are insufficient to complete the Clinical Trial Services, Seller shall produce or procure additional Clinical Trial Materials, and the Company shall reimburse Seller for the costs of producing or procuring such additional Clinical Trial Materials, at Seller’s actual cost without markup.  If any Clinical Trial Materials are lost, damaged or destroyed while in the possession, custody or control of Seller, the Company shall bear all costs of replacing such Clinical Trial Materials unless such loss or destruction results from Seller’s or its employees’, agents’, consultants’, subcontractors’ and/or other representatives’ negligence, willful misconduct or failure to handle such Clinical Trial Materials in compliance in all material respects with the terms of this Agreement, all Applicable Laws and all product and other applicable specifications, in which case, Seller shall bear all such replacement costs.  Seller shall manufacture, handle, store, use, import, export, transport, distribute and dispose of Company Inventories and other Clinical Trial Materials in compliance in all material respects with all Applicable Laws, all product and other applicable specifications, and the terms of Seller’s agreements pertaining to the Ongoing Trials, including the Pass-Through Agreements, and shall use commercially reasonable efforts to ensure that the Company Inventories and other Clinical Trial Materials are used only for purposes of conducting the Ongoing Trials in accordance with the protocols for the Ongoing Trials. Promptly following the end of the Clinical Trial Service Period, Seller shall, as directed by the Company, either make available for delivery to the Company or any of its Affiliates any of such Company Inventories and other Clinical Trial Materials inventories that remain in the possession of Seller or any of its Affiliates or destroy all such inventories of Company Inventories and other Clinical Trial Materials and provide the Company with written certification of such destruction. If the Company elects to take possession, rather than destroy, the remaining inventories of Company Inventories and other Clinical Trial Materials, the Company or its applicable Affiliate shall be responsible for arranging the delivery of such remaining inventories with Third Parties reasonably acceptable to Seller.  The Company shall bear all costs and expenses associated with destruction or delivery of such remaining inventories of Company Inventories and other Clinical Trial Materials, which, to the extent incurred by Seller, shall be reimbursed in accordance with Section 3.2.  Nothing in this Section 4.3 shall limit or alter Seller’s obligations under the Supply Agreement, the Work Order or any Change Order relating to chemistry, manufacturing and

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

19

 

controls (“CMC”) activities, including Seller’s obligations relating to manufacture of stability samples and related activities and process and manufacturing development.

 

ARTICLE 5

CONFIDENTIALITY

 

5.1          Confidentiality Obligations.  Each of Seller and the Company shall, and shall cause their respective Affiliates and Representatives to, keep completely confidential and not publish, disclose or use, directly or indirectly, for any purpose, any Confidential Information of the Disclosing Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement (including pursuant to Section 5.2).  “Confidential Information” means the terms of this Agreement and any information provided by or on behalf of Seller, on the one hand, or the Company, on the other hand (in such capacity, a “Disclosing Party”) to the other (or to any of the other’s Affiliates or Representatives) (collectively, in such capacity, a “Receiving Party”) on or after the Effective Date in connection with the Services, and shall include all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to the extent containing or reflecting such information; provided, however, that all Company Property, including all Documentation and Ongoing Trials Information, shall be the Confidential Information of the Company, and the Company shall be deemed the Disclosing Party and Seller shall be deemed the Receiving Party of all Company Property regardless of which Party generated, furnished or otherwise disclosed the Company Property.  Confidential Information shall not include any information that the Receiving Party can establish by written documentation to:

 

(a)           have been publicly known prior to disclosure by the Disclosing Party or its Affiliates or Representatives to the Receiving Party;

 

(b)           have become publicly known, without fault on the part of the Receiving Party or the Receiving Party’s Representatives, subsequent to disclosure by the Disclosing Party or its Affiliates or Representatives to the Receiving Party;

 

(c)           have been received by the Receiving Party at any time after the Effective Date, other than in connection with the Services, from a source, other than the Disclosing Party or the Disclosing Party’s Affiliates or Representatives, lawfully having possession of and the right to disclose such Confidential Information; or

 

(d)           have been otherwise known by the Receiving Party (based upon written records of the Receiving Party) prior to disclosure by the Disclosing Party or the Disclosing Party’s Affiliates or Representatives to the Receiving Party (excluding Ongoing Trial Information, any information included in the TSA Assets and the Manufacturing Technology).

 

5.2          Permitted Uses and Disclosures.  Each Receiving Party may use or disclose Confidential Information of the Disclosing Party only as follows:

 

(a)           in responding to a valid order of a Governmental Entity having jurisdiction or, if in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is otherwise required by Law; provided, however, that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

20

 

opportunity to quash such order or to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such Governmental Entity or, if disclosed, be used only for the purposes for which the order was issued (and, if requested by the Disclosing Party, the Receiving Party shall have reasonably cooperated with the Disclosing Party in connection with the foregoing); provided, further, that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such order shall be limited to that information that is legally required to be disclosed in response to such order;

 

(b)           such Confidential Information may be (i) disclosed to any of the Receiving Party’s Representatives, the Receiving Party’s Affiliates and such Affiliates’ directors, officers and employees, in each case, who (A) has a need to know such Confidential Information in connection with the Receiving Party’s performance of its obligations or exercise of its rights or remedies under this Agreement (the “Permitted Use”) and (B) is subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party pursuant to this Article 5 and (ii) used solely for the Permitted Use; provided, however, each Party shall be responsible for any failure by any Person to whom it disclosed Confidential Information of the Disclosing Party to comply with the confidentiality and use restrictions set forth in this Article 5;

 

(c)           (i) the terms of this Agreement may be disclosed and (ii) with the Disclosing Party’s prior written consent, such Confidential Information may be disclosed, in either case ((i) or (ii)) to any of the Receiving Party’s potential or actual Third Party providers of finance, investors or acquirers as may be necessary or useful in connection with their evaluation of such potential or actual financing transaction, investment or acquisition, on the condition that any such Third Party is subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party pursuant to this Article 5;

 

(d)           the Company shall have the right to disclose this Agreement if required by the rules of a stock exchange on which the Company’s securities are listed (or to which an application for listing has been submitted), provided that the Company shall submit the proposed disclosure in writing to Seller as far in advance as reasonably practicable so as to provide a reasonable opportunity for Seller to comment thereon and the Company shall accept any timely, reasonable comments provided by Seller thereon and use commercially reasonable efforts to ensure the confidential treatment of any portions of such proposed disclosure specified by Seller for redaction and confidentiality; or

 

(e)           for the avoidance of doubt, the Company shall have the right to use and disclose to any Third Party the Services to the extent reasonably necessary or useful to exploit the Services for their intended use, and the Company shall have the right to reproduce, prepare derivative works of, display, distribute, disclose, publish, transfer, use and otherwise exploit any and all Company Property.

 

5.3          Return or Destruction of Confidential Information.  Promptly following the expiration or earlier termination of this Agreement or, upon the earlier written request of a Disclosing Party, the applicable Receiving Party shall destroy or return all documentary,

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

21

 

electronic or other tangible embodiments of the Disclosing Party’s Confidential Information to which the Receiving Party does not retain rights hereunder and any and all copies thereof, including those portions of any documents that incorporate or are derived from such Confidential Information, and, in the case of destruction, provide a written certification of such destruction, except that the Receiving Party may retain copies of any Confidential Information to the extent required to (a) exercise any of its rights or remedies or perform any of its obligations under this Agreement or (b) comply with its established document retention and archiving policies.

 

5.4          Survival.  The provisions of this Article 5 shall survive for a period of ten (10) years following the termination of this Agreement.

 

ARTICLE 6

LIMITATION OF LIABILITY; INDEMNIFICATION

 

6.1          Stock Purchase Agreement. Nothing in this Article 6 shall limit, alter or amend the indemnification provisions in the Stock Purchase Agreement.

 

6.2          Indemnification.

 

6.2.1       Subject to this Article 6, the Company shall indemnify, defend and hold harmless Seller and its Affiliates and their respective directors, officers, shareholders, employees and agents (collectively, the “Seller Indemnitees”) from and against, and reimburse and compensate them for, any and all Losses incurred by any such Seller Indemnitees in connection with any suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising from or relating to (a) the breach of this Agreement by the Company or any of its Affiliates or its or their subcontractors; or (b) the negligent act or omission or willful misconduct of the Company or any of its Affiliates or its or their subcontractors in connection with this Agreement; or (c) the performance by Seller or any of its Affiliates or its or their subcontractors of Seller’s obligations under and in accordance with the terms of this Agreement, except, in each case, (i) for those Losses arising from Third Party Claims for which Seller has an obligation to indemnify any Company Indemnitee pursuant to Section 6.2.2, as to which Losses each of the Company and Seller shall indemnify the other Party and the Seller Indemnitees or the Company Indemnitees, as applicable, to the extent of its liability for such Losses, and (ii) that the Company shall have no obligation to indemnify any Seller Indemnitee under this Section 6.2.1 for any Losses in connection with Third Party Claims arising from or relating to any negligent act or omission of Seller or its Affiliates or subcontractors.

 

6.2.2       Subject to this Article 6, Seller shall indemnify, defend and hold harmless the Company, Purchaser and their Affiliates and each of their respective directors, officers, shareholders, employees and agents (collectively, the “Company Indemnitees”) from and against any and all Losses incurred by any such Company Indemnitees in connection with any Third Party Claims arising from or relating to (a) the breach of this Agreement by Seller, or any of its Affiliates or its or their subcontractors; or (b) the gross negligence or willful misconduct of Seller or any of its Affiliates or its or their subcontractors in connection with this Agreement, except, in each case, for those Losses arising from Third Party Claims for which the Company has an obligation to indemnify any Seller Indemnitee pursuant to Section 6.2.1(a) or (b), as to which Losses each of the Company and Seller shall indemnify the other Party and the Seller

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

22

 

Indemnitees or the Company Indemnitees, as applicable, to the extent of its liability for such Losses.

 

6.2.3       All indemnification claims made pursuant to this Section 6.2 shall be governed by Section 8.03(a) of the Stock Purchase Agreement, mutatis mutandis.

 

6.3          Limitation of Liability.  TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT IN CONNECTION WITH ACTUAL FRAUD AND THE PARTIES’ INDEMNIFICATION OBLIGATIONS UNDER SECTION 6.2, NEITHER THE COMPANY NOR SELLER SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, FOR LOST OR ANTICIPATED PROFITS, REVENUES OR OPPORTUNITIES OR FOR ANY DAMAGES CALCULATED BY REFERENCE TO A MULTIPLIER OF REVENUE, PROFITS, EBITDA OR SIMILAR METHODOLOGY, WHETHER OR NOT CAUSED BY OR RESULTING FROM THE ACTIONS OF SUCH PARTY OR THE BREACH OF ITS COVENANTS, AGREEMENTS, REPRESENTATIONS OR WARRANTIES HEREUNDER AND WHETHER OR NOT BASED ON OR IN WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE OR STRICT LIABILITY) OR OTHERWISE.  For clarity, Seller shall not be liable for the acts or omissions of the Pass-Through Contractors (except to the extent arising from or in connection with Seller’s or its Affiliates’ gross negligence, willful misconduct or breach of this Agreement) and the liability of the Pass-Through Contractors shall be as set forth in the Pass-Through Agreements; provided, that, if the Company suffers any Losses with respect to which any Pass-Through Contractor is obligated to indemnify, reimburse or compensate under any of the Pass-Through Agreements, Seller shall, at the Company’s request, pursue a claim for such indemnity, reimbursement or compensation and shall pay to the Company any amounts that Seller receives from such Pass-Through Contractor on account of such claim.  The maximum aggregate liability of Seller and its Affiliates to the Company or its Affiliates with respect to this Agreement shall not, in the aggregate, exceed the aggregate amount of Services Fees paid by the Company to Seller hereunder; provided, however, that, the fact that the liability of Seller and its Affiliates to the Company or its Affiliates with respect to this Agreement exceeds the Services Fees paid by the Company to Seller as of a particular time shall not preclude the Company or its Affiliates from recovering against Seller and its Affiliates to the extent of additional Services Fees paid after such time by the Company to Seller hereunder.

 

ARTICLE 7

TERM AND TERMINATION

 

7.1          Term.  This Agreement shall commence on the Effective Date and shall continue in full force and effect until the earliest of (a) the date on which this Agreement is terminated in accordance with this Article 7; (b) the expiration of the last Service Period, such that Seller is no longer obligated to provide any Services pursuant to this Agreement; and (c) the termination by the Company of the only remaining outstanding Service pursuant to Section 7.2.1, such that Seller is no longer obligated to provide any Services pursuant to this Agreement (the “Term”).  For clarity, all obligations of Seller to provide to the Company any Services under this Agreement shall cease at the end of the Term.

 

7.2          Termination of Services.

 

7.2.1       The Company may at any time prior to the end of the Term and upon sixty (60) days’ prior written notice to Seller, terminate this Agreement in its entirety or with respect

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

23

 

to any Service, on a Service-by-Service basis, whereupon, from and after the date of termination specified in such written notice, Seller’s obligation to provide such Service(s) to the Company shall cease and the Company shall have no obligation to pay Seller for such Service(s) (other than with respect to those Services requested by the Company, and performed by Seller or its Affiliates or subcontractors, and Out-of-Pocket Costs incurred, or non-cancellable commitments made, prior to termination); provided, that (a) if termination of any Service prevents Seller from providing any other Service or Services (as reasonably determined by Seller), such other Service(s) shall be deemed terminated and (b) if Seller reasonably determines that termination of such Service would materially inhibit Seller from providing any other Service or Services, Seller shall notify the Company in writing of such determination within fifteen (15) days after Seller’s receipt of the Company’s termination notice and, unless the Company withdraws its termination of such Service within fifteen (15) days after the Company’s receipt of such notice by Seller, such other Service(s) shall be deemed terminated.

 

7.2.2       In the event that either Seller or the Company materially breaches any of its obligations, covenants, agreements, representations or warranties under this Agreement (with the Party committing such material breach being referred to herein as the “Breaching Party”), Seller (if the Company is the Breaching Party) or the Company (if Seller is the Breaching Party) (the “Complaining Party”) may terminate this Agreement upon sixty (60) days’ prior written notice (such sixty (60)-day period, the “Notice Period”) to the Breaching Party, specifying the breach and its claim of right to terminate; provided, that the termination of this Agreement shall not become effective at the end of the Notice Period if (a) the Breaching Party cures such breach during the Notice Period or (b) such breach cannot be cured during the Notice Period and the Breaching Party commences and diligently pursues actions to cure such breach within the Notice Period, in which case the Breaching Party shall have an additional thirty (30)-day period to cure such breach before such termination shall become effective, provided, further, that any breach of a payment obligation hereunder shall not be subject to extension in accordance with the preceding clause (b).

 

7.2.3       Each of the Company and Seller may terminate this Agreement immediately upon written notice to the other Party if Seller or the Company, respectively, (a) files in any court or with any other Governmental Entity, pursuant to any Law of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets; (b) proposes a written agreement of composition or extension of its debts; (c) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within sixty (60) days after the filing thereof; (d) consents to the appointment or taking possession by a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of such Party or for any substantial part of its property or makes any assignment for the benefit of creditors; (e) admits in writing its inability to pay its debts generally as they become due; or (f) has issued or levied against its property any judgment, writ, warrant of attachment or execution or similar process that represents a substantial portion of its property.

 

7.2.4       Each of the Company and Seller may terminate this Agreement to the extent provided in Section 8.1.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

24

 

7.2.5       This Agreement may be terminated upon the mutual written agreement of the Company and Seller at any time.

 

7.3          Asset Transfer.  Upon termination or expiration of this Agreement, or upon termination of any Service by the Company pursuant to Section 7.2.1, Seller shall and shall cause its Affiliates to transfer and deliver to the Company, within such time periods as Seller and the Company may reasonably agree, all tangible TSA Assets and Company Property (or any portion thereof that pertains to the applicable terminated Service), including all records, data, files and other information and any work-in-process, received, generated or computed in Seller’s performance of the Services during the Term, in electronic or hard copy form; provided, however, that Seller shall not have any obligation to provide or cause its Affiliates to provide data in any format other than the format in which such data was originally generated or stored.  Upon termination or expiration of this Agreement, Seller shall not have any further obligation with respect to any Services, or, except as expressly provided in this Agreement, any TSA Assets or Company Property, including any obligation to facilitate the Company’s or any of its Affiliates’ performance, use or maintenance of any Service or asset.  Upon termination of any Service by the Company pursuant to Section 7.2.1, Seller shall not have any further obligation with respect to those Services that are terminated pursuant to Section 7.2.1.

 

7.4          Accrued Rights.  Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration.  Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.

 

7.5          Surviving Obligations.  Without limiting the foregoing, Article 1, Section 2.6, the last sentence of Section 2.8, Section 2.12, Section 2.15, Article 3 (solely as it relates to Services performed, or Out-of-Pocket Costs or Other Seller Costs incurred by Seller, in accordance with this Agreement prior to termination or expiration of this Agreement), Article 4 (excluding Section 4.2), Article 5, Article 6, Section 7.3, Section 7.4, this Section 7.5 and Article 8 shall survive the termination or expiration of this Agreement for any reason.

 

ARTICLE 8

MISCELLANEOUS

 

8.1          Force Majeure.  Except for the obligation to pay monies due and owing, neither Party shall be liable for any failure to perform or any delays in performance, and no such Party shall be deemed to be in breach or default of its obligations set forth in this Agreement, if, to the extent and for so long as, such failure or delay is due to any causes that are beyond such Party’s reasonable control and without its fault or negligence, including, without limitation, such causes as acts of God, natural disasters, fire, flood, severe storm, earthquake, civil disturbance, lockout, riot, order of any court or administrative body, embargo, acts of government, war (whether or not declared), acts of terrorism, or other similar causes (“Force Majeure Event”).  In the event of a Force Majeure Event, Seller or the Company, if prevented from or delayed in performing, shall promptly give notice to the other such Party and shall use commercially reasonable efforts to avoid or minimize the delay.  In the event that the delay continues for a period of at least thirty (30) days, the other such Party may elect to (a) suspend performance and extend the time for

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

25

 

performance for the duration of the Force Majeure Event, or (b) terminate this Agreement without any liability to any Party.

 

8.2          Independent Contractor.  The Parties and each of their respective Affiliates shall each be an independent contractor in the performance of its obligations hereunder.  No Third Party, including any employee of any Party or any of such Party’s Affiliates, shall have or acquire any rights by reason of this Agreement.

 

8.3          Assignment.  Neither this Agreement nor any of the rights or obligations of the Parties hereunder may be assigned by the Company, on the one hand, or Seller, on the other hand, without the prior written consent of Seller (in the case of the Company) or the Company (in the case of Seller), as applicable; provided, however, that subject to Section 3.6 (a) the Company, on the one hand, and Seller, on the other hand, may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without the prior written consent of the other Party, and (b) the Company may assign this Agreement to a successor to all or substantially all of the assets or business of the Company to which this Agreement relates, whether in a merger, sale of stock, sale of assets or otherwise.  Subject to the first sentence of this Section 8.3, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.  Any attempted assignment or transfer in violation of this Section 8.3 shall be null and void.

 

8.4          No Benefit to Third Parties.  Except for the rights of any indemnified Person under Article 6, this Agreement is for the sole benefit of the Parties and their respective successors and permitted assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the Parties and such successors and assigns, any legal or equitable rights hereunder.

 

8.5          Notices.

 

8.5.1       Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a “Notice”) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by email as a PDF attachment (with transmission confirmed by non-automated reply email from the recipient, provided, that any Notice received by e-mail transmission or otherwise at the addressee’s location on any Business Day after 5:00 p.m., Washington, D.C. time shall be deemed to have been received at 9:00 a.m., Washington, D.C. time on the next Business Day) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in this Section 8.5 or to such other address as the Party to whom notice is to be given may have provided to the Party giving the Notice at least ten (10) days’ prior to such address taking effect in accordance with this Section 8.5. Such Notice shall be deemed to have been given as of the date delivered by hand or internationally recognized overnight delivery service or confirmed that it was received by email. Any Notice delivered by email shall be confirmed by a hard copy delivered as soon as practicable thereafter.

 

(i)                                     If to Seller, to:

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

26

 

Eisai Inc.

100 Tice Blvd.

Woodcliff Lake, New Jersey 07677

Facsimile: (201) 746-3204

Attention: General Counsel

 

with a copy (which shall not constitute notice) to:

 

Covington & Burling LLP

One CityCenter

850 Tenth Street, NW

Washington, D.C. 20001

Attention:  Michael J. Riella

Facsimile: (202) 662-6291

E-mail: mriella@cov.com

 

(ii)                                  If to the Company, to:

 

AkaRx, Inc.

200 Garrett Street, Suite S

Charlottesville, VA 22902

Attention: Sean Stalfort

Facsimile: (434) 980-8196

 

with a copy (which shall not constitute notice) to:

 

Cooley LLP

1114 Avenue of the Americas

New York, New York 10036

Attention: Divakar Gupta

 

8.6          Severability.  If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of any Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Company and Seller.

 

8.7          Governing Law. This Agreement, the negotiation, execution or performance of this Agreement and any disputes arising under or related hereto (whether for breach of contract, tortious conduct or otherwise) shall be governed and construed in accordance with the Laws of

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

27

 

the State of Delaware, without reference to its conflicts of law principles that would result in the application of the substantive Law of any other jurisdiction.

 

8.8          Jurisdiction.  Each Party irrevocably agrees that any action, suit or proceeding against it arising out of or in connection with this Agreement or disputes relating hereto (whether for breach of contract, tortious conduct or otherwise) shall be brought exclusively in the Court of Chancery of the State of Delaware or, solely if such court lacks subject matter jurisdiction, the United States District Court sitting in New Castle County in the State of Delaware, and the appellate courts having jurisdiction thereover (collectively, the “Chosen Courts”), and hereby irrevocably accepts and submits to the exclusive jurisdiction and venue of the Chosen Courts in personam with respect to any such proceeding and waives to the fullest extent permitted by Law any objection that it may now or hereafter have that any such proceeding has been brought in an inconvenient forum.

 

8.9          Service of Process.  Each of the Parties consents to service of any process, summons, notice or document which may be served in any proceeding in the Chosen Courts, which service may be made by certified or registered mail, postage prepaid, or as otherwise provided in Section 8.5, to such Party’s address set forth in Section 8.5.

 

8.10        Waiver of Jury Trial.  EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR DISPUTES RELATING HERETO.  EACH PARTY (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 8.10.

 

8.11        Amendments and Waivers.  This Agreement may be amended, modified, superseded or canceled and any of the terms or conditions hereof may be waived only by an instrument in writing signed by each of the Company and Seller or, in the case of a waiver, by or on behalf of the Party waiving compliance.  No course of dealing between the Parties shall be effective to amend or waive any provision of this Agreement.  The waiver by a Party of any right hereunder or of the failure to perform or of a breach by any other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.  The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.

 

8.12        Joint Drafting.  The Parties have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

28

 

or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement.

 

8.13        Obligations.  To the extent any Affiliate of Seller will perform any Services or other obligations of Seller hereunder, Seller shall take any and all action necessary to cause such Affiliate to perform and fulfill Seller’s covenants, obligations and agreements under this Agreement, and shall be primarily responsible for any breach of this Agreement by such Affiliate.

 

8.14        Counterparts.  This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement.  Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.

 

8.15        Entire Agreement.  This Agreement, together with Stock Purchase Agreement, the Schedules and Exhibits expressly contemplated hereby and attached hereto, the Confidentiality Agreement, the other Ancillary Agreements and the other agreements, certificates and documents delivered in connection with the Stock Purchase Agreement or therewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement among the Parties with respect to the transactions contemplated hereby or thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof.

 

8.16        Dispute Resolution.  Except for Invoice Disputes (which shall be resolved pursuant to Section 3.5.1), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 8.16.

 

8.16.1     Either Party shall have the right to refer any Dispute to the President and Chief Executive Officer of Seller (or his or her designee with authority to resolve such Dispute) and the President and Chief Executive Officer of the Company who shall confer on the resolution of the issue.  Any final decision mutually agreed to by such officers shall be conclusive and binding on the Parties.  If such officers are not able to agree on the resolution of any such issue within fifteen (15) Business Days after such Dispute is first referred to them, either Party may, by written notice to the other Party, elect to initiate litigation in accordance with Section 8.7, Section 8.8 and Section 8.9 for purposes of having the matter settled.

 

8.16.2     Notwithstanding anything herein to the contrary, (a) any relevant time period related to a matter that is the subject of a Dispute shall be tolled during any dispute resolution proceeding under this Section 8.16 and (b) nothing in this Section 8.16 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party.  This Section 8.16 shall be specifically enforceable.

 

[Signature page follows]

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

29

 

IN WITNESS WHEREOF, Seller and the Company have duly executed this Agreement as of the date first written above.

 

	
 
    	
Eisai Inc.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Yuji Matsue
    
	
 
    	
 
    	
Name:   
    	
Yuji   Matsue
    
	
 
    	
 
    	
Title:
    	
Chairman &   CEO
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
AkaRx, Inc.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Alexander Scott
    
	
 
    	
 
    	
Name:
    	
Alexander   Scott
    
	
 
    	
 
    	
Title:   
    	
Vice   President
    

 

[Signature Page to Transition Services Agreement]

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

 

Schedule 2.1

 

Work Order

 

[***]

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

Schedule 2.1-1

 

Schedule 2.4.2

 

Key Employees

 

1) [***]

2) [***]

 

3) [***]

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

1

 

EXHIBIT A

 

Pass-Through Agreements

 

1.              See Items 3-37 in Section 3.10(a) of the Seller Disclosure Schedule.

 

2.              Master Services Agreement, dated December 23, 2010, between Eisai Limited and Phlexglobal Limited.

 

3.              Development and Manufacturing Services Agreement, dated October 29, 2012, between Eisai Pharmatechnology and Manufacturing Pvt. Ltd. and Civentichem India Pvt. Ltd.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

2

 

EXHIBIT B

 

Form of Seller IND Transfer Letter

 

[            ]

 

[                              ]

Food and Drug Administration

5901-B Ammendale Road

Beltsville, MD  20705-1266

 

	
Re:
    	
 
    	
Investigational New Drug Application   #062122/#075537/#076680
    
	
 
    	
 
    	
Change in Ownership and Official Correspondent
    
	
Product:
    	
 
    	
Avatrombopag Maleate
    

 

Dear [                 ]:

 

Reference is made to Investigational New Drug Application #062122/#075537/#076680 for Avatrombopag (the “IND”).  The purpose of this submission is to inform the Food and Drug Administration (the “Agency”) that the ownership of the IND is being transferred from Eisai Inc., 155 Tice Blvd., Woodcliff Lake, NJ to [the Company],[            ].

 

In accordance with 21 CFR 314.72, Eisai Inc. hereby notifies the Agency that effective [            ], all rights to the IND have been transferred to [the Company].  [The Company’s] letter confirming acceptance of the IND transfer will be submitted as sequence no. [            ].  [The Company] has been provided with a complete copy of the IND, including amendments and records required to be kept under 21 CFR § 314.72.  As of the date hereof, [the Company] assumes all regulatory responsibility for the IND and all agreements, regulatory obligations, promises and conditions contained therein.

 

All correspondence for this application should be sent to:

 

[            ] (primary contact)

Email: [            ]

Telephone: [            ]

Facsimile: [            ]

 

[            ] (alternate contact)

Email: [            ]

Telephone: [            ]

Facsimile: [            ]

 

All electronic files included in this submission are <10 MB.  All files were checked and verified to be free of viruses before submitting via the Gateway using Symantec Endpoint Protection,  program versions available upon request.  For technical questions regarding the electronic submission, please contact [Sung-Jun Ahn at 201-949-4531].

 

If you have any questions regarding this submission, please contact me at the number below.

 

Sincerely,

Eisai Inc.

 

[Stacie P. O’Sullivan

Associate Director, Global Regulatory Affairs

Office:  410-631-8138

Email:  Stacie_osullivan@eisai.com]

 

Cc: [            ]

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

3

 

EXHIBIT C

 

Form of Company IND Transfer Letter

 

[            ]

 

[                                  ]

Food and Drug Administration

5901-B Ammendale Road

Beltsville, MD  20705-1266

 

	
Re:
    	
 
    	
Investigational New Drug Application   #062122/#075537#076680
    
	
 
    	
 
    	
Change in Ownership — Acceptance
    
	
Product:
    	
 
    	
Avatrombopag Maleate
    

 

Dear [                       ]:

 

Reference is made to Investigational New Drug Application #062122/#075537/#076680 for Avatrombopag (the “IND”).  The purpose of this submission is to inform the Food and Drug Administration (the “Agency”) that the ownership of the IND is being transferred from Eisai Inc., 155 Tice Blvd., Woodcliff Lake, NJ to [the Company],[            ].  Reference is also made to the enclosed letter from Eisai Inc., dated [           sequence no._] transferring ownership and official correspondent of the IND to [the Company].

 

In accordance with 21 CFR 314.72, [the Company] hereby accepts the change in ownership which is effective as of [            ].  [The Company] has a complete copy of the IND including amendments and records that are required under 21 CFR 314.81 and commits to the agreements, promises and conditions made by the former owner and contained in the application.

 

Also enclosed is a revised 1571 form.  Please direct all the IND-related correspondence to the following primary and alternate contacts at [the Company]:

 

[            ] (primary contact)

Email: [            ]

Telephone: [            ]

Facsimile: [            ]

 

[            ] (alternate contact)

Email: [            ]

Telephone: [            ]

Facsimile: [            ]

 

[            ]

[            ]

[            ]

 

If you have any questions, please contact me at [            ] or by phone at [            ].  Alternatively, you may contact [            ] at [            ] or at [            ].

 

Sincerely,

 

[            ]

[            ]

 

Cc: [            ]

[            ]

 

Eisai Inc.

 

[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and  230.406.

 

4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00271-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00271-of-00352.parquet"}]]