EXECUTED VERSION

Portions of
this Exhibit have been omitted pursuant to a request for confidential treatment.

The omitted
portions are marked ***** and have been filed separately with the
Commission

 

 

 

 

 

 

 

WHEREAS,

DOR has developed and is developing, through its research activities, Beclomethasone Dipropionate (orBec®) and owns and/or controls the related KNOW-HOW and PATENT RIGHTS (as hereinafter respectively defined in Article 1); and

 

WHEREAS,

DOR and STPI signed on January 3, 2007 a Letter of Intent and on November 26, 2008 a Letter of Intent, each of which is related, inter alia, to Beclomethasone Dipropionate (orBec®), both of which are superseded by this AGREEMENT; and

 

WHEREAS,

STPI desires to obtain from DOR the right to market, distribute and sell the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY (as hereinafter respectively defined in Article 1); and

 

WHEREAS,

DOR is willing to grant to STPI such rights in the TERRITORY, under the terms and conditions hereinafter set forth; and

 

WHEREAS,

both DOR and STPI are interested in the further development of Beclomethasone Dipropionate in all therapeutic areas, diseases or conditions and in the commercial exploitation of the results of such further development.

 

 

1 -	DEFINITIONS

 

 

1.1

“AFFILIATED COMPANIES” or “AFFILIATES” means: (i) an organization more than fifty percent (50%) of the voting stock of which is owned and/or controlled directly or indirectly by either party; (ii) an organization which directly or indirectly owns and/or controls more than fifty percent (50%) of the voting stock of either party; (iii) an organization which is directly or indirectly under common control of either party through common shareholdings.

 

1.2	“AGENCY” means any regulatory authority, including the FDA, responsible for granting any marketing registration or pricing approval, if applicable, necessary so the PRODUCT and AG PRODUCT may be marketed and sold in the TERRITORY.

 

1.3	“AG PRODUCT” means a generically-labeled version of the PRODUCT (i.e., such product does not bear the TRADEMARK) supplied by DOR and sold by STPI and/or its sub-distributors or permitted sublicensees.

 

1.4	“AGREEMENT” has the meaning set forth in the introductory paragraph.

 

1.5	“APPROVAL” or “APPROVED” means all necessary approvals granted by the appropriate AGENCY for any country in the TERRITORY for the manufacture, sale and distribution of the PRODUCT and AG PRODUCT for an indication(s), which may include the FDA for the U.S.

 

1.6	“APPROVED NEW INDICATION” means a NEW INDICATION that, pursuant to Article 5.2, each of the parties, in its sole discretion, has agreed to develop.

 

1.7	“ARBITRATOR” has the meaning set forth in Appendix C.

 

1.8	“cGMP” means the current standards for the manufacture of drugs, as set forth in the U.S. Food, Drug and Cosmetics Act and applicable FDA regulations (including 21 C.F.R. Parts 210 and 211) and guidances promulgated thereunder, as amended from time to time.

 

1.9	“CODE” has the meaning set forth in Article 15.2.

 

1.10

“COMMERCIALIZATION” or “COMMERCIALIZE” means any and all activities directed to the distribution, promotion, offer for sale and sale of an APPROVED PRODUCT and AG PRODUCT, including marketing, promoting, detailing, distributing, offering to sell and selling, importing for sale, conducting post-marketing human clinical studies and interacting with any AGENCY regarding the foregoing.  For the avoidance of doubt, the term “Commercialization” or “Commercialize” does not include the right to manufacture or use.  When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.

 

1.11	“COMPANY” has the meaning set forth in the introductory paragraph.

 

1.12	“CONFIDENTIAL INFORMATION” has the meaning set forth in Article 3.3.

 

1.13	“CONTROL” means possession of the ability, whether by ownership or license, to grant a license or sublicense as provided for herein without violating the terms of any agreement, securing consent or other arrangements with any third party.

 

1.14

“DEVELOPMENT PLAN” means the schedule, attached hereto as Appendix A describing all future activities, relevant budget and timelines related to the development of the PRODUCT for the treatment of GI GVHD, including the preclinical, safety, clinical, technical, manufacturing (CMC) and regulatory development of the PRODUCT.

 

1.15

“DILIGENT EFFORTS” means, with respect to a party, the carrying out of obligations in a diligent and sustained manner  using efforts not less than the efforts that a US based pharmaceutical company of similar size to such party devotes to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, but excluding consideration of any obligation to the other party under this AGREEMENT but in no event less than the efforts of a US based pharmaceutical company of similar size to such party.  DILIGENT EFFORTS requires, inter alia, that each party:  (i) promptly assign responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis, (ii) set and consistently seek to achieve specific and meaningful objectives for carrying out such obligations, and (iii) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives.

 

1.16	“DISCLOSING PARTY” has the meaning set forth in Article 3.3.

 

1.17	“DOR” has the meaning set forth in the introductory paragraph.

 

1.18	“EFFECTIVE DATE” has the meaning set forth in the introductory paragraph.

 

1.19	“ENTERON” has the meaning set forth in the introductory paragraph.

 

1.20	“ESTIMATED QUANTITIES” has the meaning set forth in Article 8.2.

 

1.21

“EUROPEAN TERRITORY” means Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy (including the Republic of San Marino and the Vatican City), Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, The Netherlands and the United Kingdom, as well as any other country entering the European Union, Iceland, Norway and Switzerland (including Liechtenstein).

 

1.22	“EXECUTIVE COMMITTEE” has the meaning set forth in Article 4.3.

 

1.23	“FDA” means the United States Food and Drug Administration and any successor agency thereto.

 

1.24	“FIELD” means the diagnosis, treatment and/or prevention of any and all diseases and conditions.

 

1.25	“FIRM ORDER” has the meaning set forth in Article 8.3.

 

1.26

“FIRST COMMERCIAL SALE” shall mean the first commercial sale by STPI or any of its AFFILIATES or its distributors of a PRODUCT to an independent third party in the TERRITORY.  A sale or transfer which is not for value, including for clinical trial purposes, shall not constitute a FIRST COMMERCIAL SALE.

 

1.27	“FIRST PRODUCT” means the PRODUCT for the treatment of GI GVHD in humans.

 

1.28	“FIXED COMPONENT” has the meaning set forth in Appendix C.

 

1.29

“FULLY BURDENED MANUFACTURING COST” means with respect to the PRODUCT and AG PRODUCT the fully-burdened cost of manufacturing, assembling, filling, and secondary packaging of the PRODUCT and AG PRODUCT packaged for shipment to the receiving party expressed on a per unit manufactured basis, including the cost of:

 

1.29.1

material, excipients, primary and secondary packaging and labeling material, and

 

1.29.2

direct labor of supplying party employees (including basic wages, labor and related payroll taxes and benefits) incurred or spent in the actual production, filling, packaging and labeling of the PRODUCT and AG PRODUCT, including for reasonable and normal quality assurance, purchasing and manufacturing facility operations, and

 

1.29.3

overhead of supplying party (including operating expenses, indirect labor and related payroll taxes and benefits, depreciation, taxes, insurance, rent, repairs and maintenance, and supplies) incurred or spent in support of the actual production, filling, packaging and labeling of the PRODUCT and AG PRODUCT, but not for any cost of any unused manufacturing capacities that supplying party or its third party sub-contract manufacturer may have in excess of the requirements contained in the forecasts provided by receiving party in connection with this AGREEMENT, and

 

1.29.4

interim transportation, or any related transportation cost including tertiary packaging and storage of the PRODUCT and AG PRODUCT (for greater clarity, such storage cost does not include the cost of inventory) or any part thereof as incurred or spent by supplying party in connection with the supply of the PRODUCT and AG PRODUCT pursuant to the terms of this AGREEMENT, and

 

1.29.5

any third party sub-contract manufacturer as invoiced to supplying party.  Supplying party shall provide to receiving party (within one month of the EFFECTIVE DATE) the prices in effect for each sub-contract manufacturer.

 

 

1.30

“GENERIC COMPETITION” shall exist for a given PRODUCT when a GENERIC PRODUCT with the same labeled indication as the PRODUCT COMMERCIALIZED by STPI in a given country of the TERRITORY enters the market and the NET SALES of the PRODUCT during any three (3) month rolling period are at least ten percent (10%) lower than the amount of NET SALES of that PRODUCT in that same country during the three (3) month period preceding the APPROVAL of such GENERIC PRODUCT (in terms of US Dollar, or equivalent legal currency of the given country).

 

1.31	“GENERIC PRODUCT” means  a product that is APPROVED by an AGENCY (or successor agency) that contains the SUBSTANCE or salts or esters of the SUBSTANCE and utilizes the same route of administration as the PRODUCT.

 

1.32	“GI GVHD” means gastrointestinal graft vs. host disease.

 

1.33	“IMPROVEMENT” means any change, improvement, development or modification of the PATENT RIGHTS or KNOW-HOW in the FIELD that is made or created after the EFFECTIVE DATE and relates to the PRODUCT, AG PRODUCT or the SUBSTANCE or any method of use or manufacture related thereto.

 

1.34	“INITIAL TERM” has the meaning set forth in Article 14.1

 

1.35	“INSOLVENT PARTY” has the meaning set forth in Article 15.2.

 

1.36	“JOINT DEVELOPMENT COMMITTEE” means a committee with the authority to review, recommend and coordinate any research, development and regulatory activities related to the PRODUCT in the FIELD in the TERRITORY.

 

1.37	“JOINT COMMERCIALIZATION COMMITTEE” means a committee with the authority to review, recommend and coordinate any COMMERCIALIZATION activities related to the PRODUCT and AG PRODUCT in the TERRITORY.

 

1.38

“KNOW-HOW” means all information and data, technical information, trade secrets, specifications, instructions, processes, formulae, expertise and information relating to the SUBSTANCE and the PRODUCT and its sale in the FIELD owned by or under the CONTROL of DOR or any AFFILIATE thereof as of the EFFECTIVE DATE or during the term of this AGREEMENT. Such KNOW-HOW shall include all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, relevant to the sale of the SUBSTANCE which may be useful in the sale of the SUBSTANCE or the PRODUCT.

 

1.39	“MARKETING AUTHORIZATIONS” mean the authorizations issued by the AGENCY which are necessary for the marketing, use, distribution and sale of the PRODUCT and AG PRODUCT in the TERRITORY.

 

1.40	“MCDONALD” has the meaning set forth in Article 2.7.

 

1.41	“MCDONALD LICENSE” has the meaning set forth in Article 2.7.

 

1.42	“NDA” means the New Drug Application and all amendments and supplements thereto for the PRODUCT submitted by DOR to the FDA, including all documents, data and other information included in an accepted NDA submission for APPROVAL to market and sell the PRODUCT in the TERRITORY.

 

1.43

“NET SALES” mean, with respect to each PRODUCT and AG PRODUCT, the gross invoiced sales price of such PRODUCT and AG PRODUCT billed by or on behalf of STPI, its AFFILIATES, sub-licensees (if permitted), distributors or agents to third parties on sales of a PRODUCT and AG PRODUCT in bona fide arm’s length transactions in the TERRITORY, less the following deductions, determined in accordance with U.S. generally accepted accounting principles as then in effect and consistently applied, to the extent included in the gross invoiced sales price for such PRODUCT or AG PRODUCT or otherwise directly paid or incurred by STPI, its AFFILIATES or sub-licensees (if permitted), distributors or agents with respect to the sale of such PRODUCT and AG PRODUCT:

 

1.43.1

normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of such PRODUCT and AG PRODUCT;

 

1.43.2

normal and customary amounts repaid or credited by reason of rejections, returns and allowances;

 

1.43.3

normal and customary third party cash rebates and chargebacks related to sales of the PRODUCT and AG PRODUCT, if and to the extent allowed under applicable laws of the TERRITORY (including shelf stock adjustments in the case of an AG PRODUCT);

 

1.43.4

tariffs, duties, excise, sales, value-added or other taxes (other than taxes based on income);

 

1.43.5

normal and customary cash discounts for timely payment;

 

1.43.6

normal and customary discounts pursuant to indigent patient programs and patient discount programs, including without limitation coupon discounts and co-pay assistance programs; and

 

1.43.7

any other normal and customary specifically identifiable costs or charges included in the gross invoiced sales price of such PRODUCT falling within categories substantially equivalent to those listed above.

 

 

1.44	“NEW INDICATION” means any indication other than for the treatment of GI GVHD which the JOINT DEVELOPMENT COMMITTEE agrees to develop and for which STPI or its AFFILIATES are granted exclusive COMMERCIALIZATION rights hereunder.

 

1.45

“PATENT RIGHTS” means all the patents and the patent applications claiming the SUBSTANCE and/or the PRODUCT (as the case may be) or its use and manufacture in the FIELD owned and/or under the CONTROL of DOR as listed in Appendix B to this AGREEMENT, as well as: (i) all patents arising from said applications; (ii) any additions, divisions, continuations, continuations-in-part, amendments, amalgamations and reissues of such applications or patents; (iii) any confirmation, importation or registration patents thereof or therefor; and (iv) any extensions and renewals of all such patents and/or patent applications in whatever legal form and/or by whatever legal title they are granted, including Supplementary Protection Certificate(s) or equivalent.

 

1.46	“PERCENTAGE COMPONENT” has the meaning set forth in Appendix C.

 

1.47

“PHARMACOVIGILANCE AGREEMENT” means the agreement that defines how the parties are to cooperate to enable each of them to comply with its respective obligations under applicable laws, regulations and guidelines with regard to the adverse event collection, evaluation, reporting and communicating any safety issues for the PRODUCT, both pre- and post-marketing and to enable each party to satisfy its duty of care, which the parties hereto shall negotiate in good faith and enter into within sixty (60) days of the EFFECTIVE DATE.

 

1.48

“PHASE 3 TRIAL” means the clinical study BDP-GVHD-03 entitled, “A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) in Conjunction with Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients with Gastrointestinal Graft vs. Host Disease”.

 

1.49	“PRODUCT” means any product in finished pharmaceutical form APPROVED for use, manufacture and sale in the FIELD containing the SUBSTANCE.

 

1.50	“QUALITY ASSURANCE AGREEMENT” shall have the meaning set forth in Article 6.3 of this AGREEMENT, which the parties hereto shall negotiate in good faith and enter within sixty (60) days of the EFFECTIVE DATE.

 

1.51	“RECEIVING PARTY” has the meaning set forth in Article 3.3.

 

1.52	“ROFN NOTICE” has the meaning set forth in Article 2.2.

 

1.53	“SOLVENT PARTY” has the meaning set forth in Article 15.2.

 

1.54	“SPECIFIED INDICATION” has the meaning set forth in Article 2.8.

 

1.55	“SUBSTANCE” means Beclomethasone Dipropionate.

 

1.56	“SUPPLY PRICE” means the supply price for the PRODUCT and AG PRODUCT as set forth in Appendix C attached hereto.

 

1.57	“TERRITORY” means the United States of America (including its territories and possessions, as well as Puerto Rico), Canada and Mexico.

 

1.58	“TRADEMARK” means orBec® as well as any and all trademark/s, their back-ups and clones, which shall be owned or under the CONTROL of DOR or of any of its AFFILIATED COMPANIES and shall be used to identify the PRODUCT in the TERRITORY, including domain names.

 

1.59

“VALID CLAIM” means, on a country-by-country basis, a granted claim within the PATENT RIGHTS which has not been held invalid and/or unenforceable in a decision of a patent office, court or other government agency of competent jurisdiction, unappealable or unappealed within the time frame allowed for appeal.

 

 

(The information below marked by ***** has been
omitted by a request for confidential treatment. The omitted portion has been
separately filed with the Commission.)

 

2 -	GRANT OF RIGHTS

 

2.1

Subject to the terms and conditions hereof, DOR hereby appoints STPI as its exclusive distributor of PRODUCTS and AG PRODUCTS in the FIELD in the TERRITORY (even as to DOR), and, in connection therewith and to support the distribution rights granted hereunder, grants to STPI and STPI hereby accepts an exclusive (even as to DOR) license, with no right to grant sub-licenses, to COMMERCIALIZE the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY, under the TRADEMARK, the PATENT RIGHTS and under the KNOW-HOW, including marketing, detailing, conducting post-marketing human clinical studies and interacting with any AGENCY regarding the foregoing.  For purposes of clarification, STPI shall not have the right to develop, modify, manufacture or have manufactured the SUBSTANCE or the PRODUCT or AG PRODUCT, except as authorized by the JOINT DEVELOPMENT COMMITTEE and agreed between the parties and subject to Article 8.9 below.  Subject to the terms and conditions hereof and solely in support of the rights granted hereunder in the remainder of the AGREEMENT, DOR hereby agrees that, with respect to any third party, it will exclusively manufacture and supply STPI with all STPI’s requirements of the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY.  STPI shall have the right to appoint distributors of the PRODUCT and AG PRODUCT, provided, however, in each case such distributor agrees in writing to abide by the terms of this AGREEMENT and, in the case of a distributor that is not an AFFILIATE of STPI, such distributor is approved in advance by DOR, which approval shall not be unreasonably withheld or delayed.  STPI shall notify DOR of any AFFILIATED distributor promptly upon their appointment.

 

2.2

*****

 

2.3

Regulatory.  DOR shall be the holder of the MARKETING AUTHORIZATIONS.  DOR  shall provide to STPI copies of any Investigational New Drug or other health registration documents and amendments or supplements thereto filed with the FDA (or other similar AGENCY) by DOR and all correspondence to and from such AGENCY (or other similar AGENCY) relevant to the SUBSTANCE or the PRODUCT in the FIELD in the TERRITORY.

 

2.4

Assignment of Improvements.  Subject to the terms and conditions hereof, STPI hereby assigns to DOR the IMPROVEMENTS made, invented or conceived by STPI (and its AFFILIATES but only if such AFFILIATES are appointed as distributors hereunder or receive any CONFIDENTIAL INFORMATION of DOR) after the EFFECTIVE DATE and agreed to take any and all actions, make and execute any and all assignments and make any filings in order to facilitate the foregoing.

 

2.5	No Sale Outside Territory.

 

2.5.1

During the term hereof, STPI shall not and shall cause its AFFILIATES not to, directly or indirectly, including through the use of one or more agents or persons with whom STPI and/or its Affiliates are in privity of contract: (i) sell, distribute or otherwise dispose of; or (ii) grant any license or other right or otherwise distribute or dispose of, PRODUCT in the FIELD outside the TERRITORY.

 

2.5.2

During the term hereof, DOR shall not and shall cause its AFFILIATES not to, directly or indirectly, including through the use of one or more agents or persons with whom DOR and/or its Affiliates are in privity of contract: (i) sell, distribute or otherwise dispose of; or (ii) grant any license or other right or otherwise distribute or dispose of, PRODUCT in the FIELD within the TERRITORY.

 

2.6	Exclusive Relationship in GI GVHD.

 

2.6.1

Except pursuant to terms of this Agreement, during the term hereof, STPI shall not, itself or through any AFFILIATE, COMMERCIALIZE (i) a product for the treatment or prevention of GI GVHD or any APPROVED NEW INDICATION in the TERRITORY or (ii) a PRODUCT in the TERRITORY in the FIELD.

 

2.6.2

Except pursuant to terms of this Agreement, during the term hereof, DOR shall not, itself or through any AFFILIATE, COMMERCIALIZE (i) a product for the treatment or prevention of GI GVHD or any NEW INDICATION in the TERRITORY or (ii) a PRODUCT in the TERRITORY in the FIELD.

 

2.7

McDonald License.  STPI acknowledges that the certain of the rights granted hereunder are rights which DOR has received through the Exclusive License Agreement dated as of November 24, 1998 (the “MCDONALD LICENSE”) by and between George McDonald (“MCDONALD”) and ENTERON, a copy of which is attached hereto as Appendix E, and which contains certain terms and conditions set forth therein.  Without limiting the foregoing, STPI expressly acknowledges the reservation of rights of MCDONALD set forth in Sections 2B(vi) and (vii).  STPI further acknowledges and agrees that any information provided herein to DOR by STPI hereunder may be included in one or more development reports made to MCDONALD pursuant to Section 3A of the MCDONALD LICENSE.  STPI further acknowledges that all representations and warranties made in this AGREEMENT are made by DOR and not MCDONALD, who has specifically disclaimed representations as set forth in Section 4D of the MCDONALD LICENSE.  STPI agrees to reasonably cooperate with DOR to enable DOR to fulfill its obligations under Section 5 of the MCDONALD LICENSE.  Neither STPI nor any distributor of STPI shall use the trade names or marks of MCDONALD (including any contraction, abbreviation or simulation of the foregoing) in connection with the COMMERCIALIZATION of any PRODUCT except where required by law.  STPI agrees that it shall not enter into any discussions or communications with MCDONALD, directly or indirectly, during the term of this AGREEMENT regarding any license or transaction under this AGREEMENT, except in respect of COMMERCIALIZATION of the PRODUCT.  STPI shall not intentionally take any action or omit to take any action which would cause DOR to be in default under the MCDONALD LICENSE.  Notwithstanding anything to the contrary contained in this AGREEMENT, during the term of this AGREEMENT, (i) DOR shall provide STPI with copies of any notices provided by DOR to MCDONALD which relate to any claim or action by DOR to terminate the MCDONALD LICENSE and (ii) DOR shall not terminate the MCDONALD LICENSE pursuant to Section 6E of the MCDONALD LICENSE, as such Section may be amended.  The parties agree that irreparable damage would occur in the event the obligations set forth in the preceding sentence were not performed in accordance with the terms thereof and that STPI shall be entitled to specific performance of the terms thereof in addition to any other remedy at law or in equity, including monetary damages, that may be available to it.  The COMPANY agrees that ENTERON shall remain a wholly owned subsidiary of the COMPANY during the term of this AGREEMENT, provided, however, the COMPANY may merge ENTERON with and into the COMPANY at its discretion.

 

2.8

Notwithstanding the rights provided in Article 2.1, STPI (i) shall have the right to market, sell, offer for sale, and have sold AG PRODUCT for a labeled indication (the “SPECIFIED INDICATION”) only beginning (A) on the date on or, with DOR’s prior written consent, not to be unreasonably withheld, prior to the anticipated date that a third party sells or offers for sale a generically-labeled version of the PRODUCT APPROVED for the SPECIFIED INDICATION for which such PRODUCT is APPROVED or (B) if applicable, upon (or as part of) settlement of a litigation under Article 10.3 that allows a third party to sell or offer for sale a generically-labeled version of the PRODUCT APPROVED for the SPECIFIED INDICATION and (ii) shall not have a general right to sublicense, but shall have the limited right to grant sublicenses only under its rights to market, sell, offer for sale, and have sold AG PRODUCT for the SPECIFIED INDICATION and only in connection with settlement of a litigation under Article 10.3 that allows a third party to sell or offer for sale a generically-labeled version of the PRODUCT APPROVED for the SPECIFIED INDICATION, provided that STPI has obtained the consent of DOR and MCDONALD to such settlement to the extent required under Article 10.3.  STPI will at all times remain responsible to DOR for all of its obligations under this AGREEMENT and shall be responsible for the acts or omissions of its sublicensees in exercising rights granted hereunder.  Each sublicense granted by STPI shall be consistent with the terms of this AGREEMENT, and STPI shall furnish DOR a copy of any such sublicense it grants.

 

3 -	EXCHANGE OF INFORMATION, CONFIDENTIALITY, PHARMACOVIGILANCE.

 

3.1

DOR shall promptly disclose, at its own cost, to STPI on an ongoing basis during the term of this AGREEMENT, in writing, or via mutually acceptable electronic media, copies or reproductions of all PRODUCT-related information under the CONTROL of DOR, but only to the extent not previously disclosed to STPI, that are reasonably necessary or useful for STPI and its sub-distributors to COMMERCIALIZE the PRODUCT in the TERRITORY, including any KNOW-HOW and PATENT RIGHTS under the CONTROL of DOR.

 

3.2

Furthermore, each party shall promptly disclose to the other through the JOINT DEVELOPMENT COMMITTEE on an ongoing basis during the term of this AGREEMENT any and all progress made on development and regulatory activities relating to the SUBSTANCE and/or the PRODUCT. STPI shall be informed in advance of any FDA meeting/request related to such development and shall have the right to send up to two (2) representatives to attend to such FDA meetings.

 

3.3

Both DOR and STPI agree to keep and have kept in strict confidence all confidential information and data (hereinafter “CONFIDENTIAL INFORMATION”) received from the other party under the terms of this AGREEMENT. DOR and STPI agree to use CONFIDENTIAL INFORMATION only for the purposes of this AGREEMENT and pursuant to the rights granted by the recipient under this AGREEMENT. In particular DOR and STPI agree not to disclose such information and data to any third party other than:

 

3.3.1

their respective AFFILIATED COMPANIES; or

 

3.3.2

a third party solely to the extent necessary for furthering the purposes of this AGREEMENT, provided that the third party agrees in writing to maintain the confidentiality of the CONFIDENTIAL INFORMATION in a manner consistent with the confidentiality provisions of this AGREEMENT; or

 

3.3.3

in connection with seeking MARKETING AUTHORIZATIONS outside the TERRITORY.

 

 

 

3.4

The secrecy obligations herein shall last during and for a period of five (5) years, and ten (10) years with respect to KNOW-HOW, after any termination of this AGREEMENT, subject to the exceptions set forth herein.  The obligations of confidentiality and use of information and data above shall not apply with regard to that information and those data which:

 

3.4.1

the RECEIVING PARTY can show in writing were known to it or to its AFFILIATES at the time of disclosure, and/or

 

3.4.2

are public knowledge at the time of disclosure to the RECEIVING PARTY, and/or

 

3.4.3

become public knowledge at a later date without any fault of the RECEIVING PARTY, and/or

 

3.4.4

are independently developed by the RECEIVING PARTY or its AFFILIATES, as competently proven.

 

3.5	DOR and STPI agree that they shall refer any serious adverse event or significant clinical safety information which they have knowledge thereof to the other party according to the procedure to be agreed upon separately and documented in the PHARMACOVIGILANCE AGREEMENT.

 

3.6

Any proposed written publications of a party relating to PRODUCT and AG PRODUCT shall be cleared for release by the other party.  The disclosing party shall provide a copy of the proposed written publication to the reviewing party at least thirty (30) days prior to the intended date of release. The reviewing party shall have thirty (30) days from receipt of the proposed written publication to provide comments and/or proposed changes to the disclosing party. These timelines will be reduced to respectively ten (10) and five (5) working days in the case of abstracts. In the event the disclosing party does not accept the comments and/or proposed changes, DOR and STPI shall further discuss, and mutually agree upon, the final wording of the written publication. Thereby, due regard shall be given to the receiving party’s legitimate interests, e.g., obtaining optimal patent protection, coordinating and maintaining the proprietary nature of submissions to AGENCIES, and protection of confidential data and information. The review period may be extended for an additional two (2) months to permit the reviewing party to file one or more patent applications as it deems appropriate. While publications and presentations by outside investigators may be difficult to control, both STPI and DOR shall use reasonable efforts to gain the right to review publications and presentations relating to the PRODUCT and AG PRODUCT by such outside investigators. This Article 3.6 shall not apply to disclosures to the financial community, including investor conferences and analysts’ meetings/reports, provided that such disclosure does not undermine the validity of any claims in a prospective patent application.

 

4 -	JOINT DEVELOPMENT COMMITTEE

 

4.1

As soon as possible after the EFFECTIVE DATE, DOR and STPI shall appoint a JOINT DEVELOPMENT COMMITTEE in which both parties are equally represented by three (3) members designated by each party. A party may change one or more of its representatives to the JOINT DEVELOPMENT COMMITTEE at any time.  The Chairman of the JOINT DEVELOPMENT COMMITTEE shall be a representative appointed by DOR.

 

4.2

Meetings of the JOINT DEVELOPMENT COMMITTEE shall be held at locations designated by the parties approximately every three (3) months or as the JOINT DEVELOPMENT COMMITTEE may deem necessary. At these meetings, progress of the work over the preceding period shall be discussed and the parties will discuss, formulate and agree to plans, including plans and strategy for the regulatory dossiers, to achieve the goals of the collaboration.  Also, at these meetings DOR will supply STPI with progress reports summarizing any and all clinical, technical and manufacturing activities conducted over the prior three-month period. At these meetings either party shall be entitled to ask and to receive from the other party any detail on any and all aspects of the activities performed by the other party. The Chairman shall prepare or have prepared the minutes reporting in reasonable detail the actions taken by the JOINT DEVELOPMENT COMMITTEE, the issues requiring resolution and resolutions of previously reported issues, which minutes are to be signed by a representative of each party, promptly after each meeting. In the first meeting of the JOINT DEVELOPMENT COMMITTEE the parties shall discuss and agree upon a common policy to be used in answering any inquiries from and/or in making any communications to any AGENCY in the TERRITORY.

 

4.3

Any decision by the JOINT DEVELOPMENT COMMITTEE shall be taken on a consensus basis, by the majority of the elected members. In the event the JOINT DEVELOPMENT COMMITTEE is unable to reach a decision by consensus, the matter(s) in dispute shall be referred to an executive committee (hereinafter “EXECUTIVE COMMITTEE”) for decision. The EXECUTIVE COMMITTEE shall consist of the President of STPI (or its designee) and the President of DOR (or its designee), provided however any final determination shall be made by DOR.

 

4.4

DOR shall use DILIGENT EFFORTS to carry out development of the PRODUCT in accordance with the DEVELOPMENT PLAN.  If DOR determines that it will be unable to accomplish any of the key clinical events identified in the DEVELOPMENT PLAN, it shall promptly notify the JOINT DEVELOPMENT COMMITTEE at the next regularly scheduled meeting, and if necessary, DOR shall develop a revised DEVELOPMENT PLAN for the PRODUCT, to be agreed upon in good faith between the parties.

 

4.5	Each party shall bear all expenses of its representatives related to their participation in the JOINT DEVELOPMENT COMMITTEE.

 

5 -	DEVELOPMENT

 

5.1

DOR shall use DILIGENT EFFORTS in connection with, and shall be responsible for conducting or having conducted through a Contract Research Organization, the development of the PRODUCT according to the DEVELOPMENT PLAN, at DOR’s sole costs and expenses, which development includes the completion of the PHASE 3 TRIAL and the assemblage of the registration dossier so that the MARKETING AUTHORIZATIONS can be filed by DOR with the competent AGENCY in the TERRITORY.

 

5.2

It is expected that the PRODUCT development will be related first to the use of the PRODUCT in the treatment of GI GVHD.  If either DOR or STPI determines that additional development may yield new indications for PRODUCT, the parties agree to negotiate in good faith, without obligation, the potential for a sharing of costs, milestones, or any other mutually acceptable arrangement that would encourage such development. In the event the parties reach an agreement, this AGREEMENT would be amended in writing accordingly.

 

5.3

DOR agrees to supply, free of charge, the PRODUCT necessary to conduct the PHASE 3 TRIAL as well as any clinical trial as approved by the JOINT DEVELOPMENT COMMITTEE in order to pursue the fullest development.  Any PRODUCT  required for any Phase 4 studies that are required by or negotiated with the FDA as a condition to obtaining or maintaining APPROVAL of the PRODUCT shall be supplied by DOR free of charge.  Any PRODUCT required for any Phase 4 studies requested by STPI that are not required by or negotiated with the FDA as a condition to obtaining or maintaining APPROVAL of the PRODUCT shall be supplied by DOR at DOR’s FULLY BURDENED COST.

 

5.4

DOR shall promptly supply STPI with the results of the PHASE 3 TRIAL as well as with any and all results and documentation arising from any studies conducted by DOR. DOR grants STPI the right to use these results and documentation for COMMERCIALIZATION and pharmacovigilance purposes for the PRODUCT in the FIELD in the TERRITORY.

 

5.5	As supplier of the PRODUCT and AG PRODUCT, DOR shall be responsible for filing or having applicable vendors/suppliers file drug master files with respect to the SUBSTANCE and PRODUCT with all relevant AGENCIES in the TERRITORY in accordance with the DEVELOPMENT PLAN.

 

5.6

The parties shall cooperate in good faith with respect to the conduct of any inspections by an AGENCY of a party’s site and facilities related to the PRODUCT and AG PRODUCT.  To the extent either party receives any material written or oral communication from an AGENCY relating to the APPROVAL process with respect to the PRODUCT in the TERRITORY, the party receiving such communication shall promptly notify the other party and provide a copy of such written communication and/or a written summary of such oral communication as soon as reasonably practicable.  The parties shall cooperate in good faith with respect to all regulatory filings required under this AGREEMENT.

 

5.7

DOR acknowledges that certain PRODUCT-related activities undertaken by DOR outside of the TERRITORY may trigger material reporting obligations to an AGENCY and may materially affect the COMMERCIALIZATION of the PRODUCT by STPI in the TERRITORY, and with respect to such activities that DOR determines in good faith are likely to trigger such material reporting obligations and/or are likely to materially affect such COMMERCIALIZATION by STPI, DOR shall disclose such PRODUCT-related activities outside of the TERRITORY to STPI and permit STPI to promptly review them and provide comments and suggestions that would enable both parties to achieve their objectives under this AGREEMENT.  Similarly, STPI shall disclose any PRODUCT-related activities within the TERRITORY to DOR and permit DOR to promptly review them and provide comments and suggestions that would enable both parties to achieve their objectives under this AGREEMENT.  If the parties are unable to reach mutual agreement regarding a fair and reasonable approach that would avoid or minimize any material reporting obligations and material effects on COMMERCIALIZATION of the PRODUCT by STPI, such dispute or disagreement shall be resolved pursuant to Article 17.

 

5.8

DOR shall conduct any post-APPROVAL development programs for the PRODUCT in the TERRITORY, including Phase 4 studies, that are required by or negotiated with the FDA as a condition to obtaining or maintaining APPROVAL of the PRODUCT.  The cost and expense of any such programs related to treatment of GI GVHD shall be borne by DOR.  The cost and expense of any Phase 4 studies requested by STPI that are not required by or negotiated with the FDA as a condition to obtaining or maintaining APPROVAL of the PRODUCT shall be borne by STPI.

 

6 -	REGISTRATION, COMMERCIALIZATION.

 

6.1	DOR will own the NDA or submission filed by DOR with any AGENCY to obtain the MARKETING AUTHORIZATIONS in any country of the TERRITORY.  DOR will also own all MARKETING AUTHORIZATIONS.

 

6.2

DOR shall file applications for and maintain MARKETING AUTHORIZATIONS for the PRODUCT in the FIELD in the TERRITORY with the competent AGENCY in the TERRITORY in DOR’s own name and costs. DOR shall at its own cost and expense obtain and comply with all authorizations, licenses, permits and regulations which may from time to time be required from any AGENCY in the TERRITORY to enable DOR to obtain and maintain MARKETING AUTHORIZATIONS.

 

6.3

DOR, directly and/or through the manufacturer/s of the PRODUCT and AG PRODUCT, and STPI will enter into the QUALITY ASSURANCE AGREEMENT, which will set forth in detail the responsibilities of the parties concerning manufacturing, control, and release of the PRODUCT and AG PRODUCT.  The QUALITY ASSURANCE AGREEMENT will also address, but not be limited to, preliminary specifications, raw material purchasing and controls, analytical documentation, costs of quality assurance and other matters relating to compliance with cGMP in the TERRITORY.

 

6.4	STPI shall be responsible for the promotion, marketing and distribution of the PRODUCT and AG PRODUCT in the FIELD in the TERRITORY, and the creation, if any, of associated marketing collaterals, inserts, advisory information or material or the like.

 

6.5	Joint Commercialization Committee.

 

6.5.1

Promptly after the EFFECTIVE DATE, the parties shall appoint a JOINT COMMERCIALIZATION COMMITTEE in which both parties are equally represented by three (3) members designated by each party. A party may change one or more of its representatives to the JOINT COMMERCIALIZATION COMMITTEE at any time.  The Chairman of the JOINT COMMERCIALIZATION COMMITTEE shall be a representative appointed by STPI.

 

6.5.2

Any decision by the JOINT COMMERCIALIZATION COMMITTEE shall be taken on a consensus basis, by the majority of the elected members. In the event the JOINT COMMERCIALIZATION COMMITTEE is unable to reach a decision by consensus, the matter(s) in dispute shall be referred to the EXECUTIVE COMMITTEE for decision, provided however any final determination shall be made by STPI.

 

6.5.3

Meetings of the JOINT COMMERCIALIZATION COMMITTEE shall be held at locations designated by the parties approximately every three (3) months; via teleconferencing or as the JOINT COMMERCIALIZATION COMMITTEE may deem necessary.  In furtherance of its responsibility for overseeing the COMMERCIALIZATION of the PRODUCT, the JOINT COMMERCIALIZATION COMMITTEE shall perform the following activities:

 

(i)	review strategy for COMMERCIALIZATION of PRODUCT, including product positioning;

 

(ii)	coordinate with the JOINT DEVELOPMENT COMMITTEE as appropriate;

 

(iii)

review and comment on marketing plans;

 

(iv)	facilitate the flow of information with respect to the COMMERCIALIZATION of the PRODUCT and AG PRODUCT;

 

(v)	coordinate plans for labeling and selecting TRADEMARKS for PRODUCT and AG PRODUCT in the TERRITORY;

 

(vi)	review and comment on advertising and promotional materials, including medical education, symposia, opinion leader development, peer-to-peer development, publications and journal ads;

 

(vii)

design, in collaboration with the JOINT DEVELOPMENT COMMITTEE, Phase 4 studies, and review use and dissemination of such resulting data;

 

(viii)

review and comment on final packaging, and plan and oversee educational and professional symposia and speaker and peer-to-peer activity programs;

 

(ix)	recommend to the JOINT DEVELOPMENT COMMITTEE whether to seek NEW INDICATIONS, formulations or uses for the PRODUCT and AG PRODUCT, such as for PRODUCT and AG PRODUCT life cycle management;

 

(x)	work with the JOINT DEVELOPMENT COMMITTEE for approval of early access and compassionate use programs.

 

 

6.6	STPI shall at all times use DILIGENT EFFORTS in the COMMERCIALIZATION in the TERRITORY of the PRODUCT and AG PRODUCT.

 

6.7	Each party shall bear all expenses of its representatives related to their participation in the JOINT COMMERCIALIZATION COMMITTEE.

 

 

7 -

TRADEMARK

 

7.1	STPI agrees that the TRADEMARK shall be owned, controlled and maintained (including filing, watching, renewals) by DOR, at DOR’s sole costs and expenses, for the duration of this AGREEMENT.

 

7.2

DOR agrees to take promptly all reasonable legal action necessary to protect the TRADEMARK against any infringement by third parties. If within sixty (60) days following notice of a possible infringement of the TRADEMARK, DOR decides not to take action to restrain such infringement, STPI shall, in its sole discretion, have the right to take such action as it deemed necessary or desirable. Each party agrees to render such reasonable assistance the other party may reasonably request (e.g. necessary Powers of Attorney). Costs of any action brought by either party here under and recovery achieved as a result thereof, shall belong to DOR.

 

7.3	Should any settlement or judicial finding which is reviewable by a higher authority arise as a result of such action, then STPI and DOR shall reasonably consult before accepting any settlement or judicial finding which is reviewable by a higher authority.

 

7.4

STPI agrees to comply with the trademark usage standards attached to this AGREEMENT as Appendix D.  From time to time, or upon the request of DOR, STPI agrees to supply DOR with a sample of advertisements, marketing material and the promotional material bearing the TRADEMARKS prior to their use for the purpose of enabling DOR to have thirty (30) days to examine and approve the foregoing.

 

8 -	MANUFACTURING AND SUPPLY OF THE PRODUCT

 

8.1

In order to ensure that the manufacture of the PRODUCT and AG PRODUCT conforms to the highest quality standards: (i) STPI undertakes to purchase all its requirements of the PRODUCT and AG PRODUCT from DOR at the SUPPLY PRICE set forth in Appendix C to this AGREEMENT; and (ii) DOR undertakes to manufacture and supply STPI with all STPI’s requirements of the PRODUCT and AG PRODUCT.

 

8.2

Forecasts.  In order to assist DOR in its production planning, STPI shall submit to DOR as soon as possible before the launching of the PRODUCT and AG PRODUCT by STPI, its best estimates of its purchase requirements of PRODUCT and AG PRODUCT for the first twelve (12) months, together with projected delivery dates.  Thereafter, not later than the 10th working day of each calendar month, STPI shall submit to DOR its best estimates of its purchase requirements (“ESTIMATED QUANTITIES”) and delivery dates of PRODUCT and AG PRODUCT for the following twelve (12) calendar months, broken down into requirements for each calendar month.

 

8.3

Firm Orders.  Not less than ninety (90) calendar days prior to the beginning of each calendar month, STPI shall submit to DOR a binding purchase order for its requirements of PRODUCT and AG PRODUCT in such month (“FIRM ORDER”).   The quantity in each FIRM ORDER for PRODUCT and AG PRODUCT shall not be less than seventy-five percent (75%) nor more than one hundred twenty-five percent (125%) of the ESTIMATED QUANTITY for such PRODUCT and AG PRODUCT for any calendar month as most recently updated.  Notwithstanding the foregoing, DOR shall use DILIGENT EFFORTS to fill requested revisions of FIRM ORDERS that are in excess of one hundred twenty-five percent (125%) of the ESTIMATED QUANTITY.  DOR shall deliver the PRODUCT and AG PRODUCT at the requested delivery dates set forth in the FIRM ORDER, which dates shall have been agreed upon by the parties in advance as commercially reasonable.

 

8.4

Delivery.  DOR shall deliver or arrange for the delivery of PRODUCT and AG PRODUCT ordered by STPI CIP (ICC Incoterms 2000) to STPI’s warehouses in the U.S.  DOR shall provide STPI with certificates of analysis related to the PRODUCT and AG PRODUCT for each batch released for delivery hereunder.  These certificates will document that each batch received by STPI conforms to the agreed upon specifications and is otherwise in conformity with Article 8.6.  A copy of each certificate shall be included with each batch delivered to STPI.

 

8.5

At STPI’s expense, DOR shall allow STPI’s employees, consultants or other representatives upon prior written notification, at all reasonable business times, to visit and inspect the premise(s) used directly or indirectly by DOR or its subcontractors or AFFILIATES for the manufacturing (e.g. processing, packing, etc.) of the SUBSTANCE, PRODUCT and/or AG PRODUCT, but in any event not more than once annually unless DOR has received a warning letter from the FDA and then such visits may be conducted more frequently as reasonably necessary to provide assurances to STPI until the defects listed in such warning letter are remedied.  STPI warrants that all such inspections and audits shall be carried out in a manner so as not to unreasonably interfere with DOR’s, its subcontractors’ or its AFFILIATES’ conduct of business and to insure the continued confidentiality of DOR’s business and technical information.  Further, STPI agrees to comply with all of DOR’s safety and security requirements during any visits to the DOR, its subcontractors’, or AFFILIATES’ facilities.  STPI agrees to make promptly available to DOR any external reports from such facility visit(s).

 

8.6

DOR represents and warrants that the PRODUCT and AG PRODUCT manufactured by or on behalf of DOR shall (i) meet the specifications set forth in the registration dossier and MARKETING AUTHORIZATIONS and (ii) be manufactured and packaged in compliance with applicable law, including cGMP.  DOR will be responsible for labeling and packaging of PRODUCT and AG PRODUCT for final distribution, utilizing TRADEMARKS and artwork provided by STPI to DOR in accordance with the terms hereof.  Any claim under this representation and warranty shall be governed by Article 8.8.  The provisions of this Article 8.6 shall not in any way limit DOR’s indemnification obligations under Article 13.2.

 

 

8.7	The SUPPLY PRICE for the PRODUCT and AG PRODUCT supplied and delivered to STPI in accordance with this AGREEMENT shall be paid to DOR in accordance with the provisions of Appendix C hereof.

 

8.8

Claims.  All claims made concerning quality, loss or other defects in any PRODUCT must be made to DOR in writing within thirty (30) days following delivery of the PRODUCT and AG PRODUCT to STPI; provided, however, that other than with respect to defects or other non-compliance plainly observable from a visual inspection, any acceptance or deemed acceptance shall not adversely affect or otherwise diminish STPI’s rights to receive shipments of the PRODUCT and AG PRODUCT in compliance with the requirements of Article 8.6 or its rights in respect of Article 13.  At DOR’s request, STPI shall forward for inspection a representative sampling of the PRODUCT and AG PRODUCT or any part thereof that is the subject of STPI’s claim.  DOR shall inspect such samples and, if it concurs with STPI’s claim, shall promptly replace the defective PRODUCT and AG PRODUCT without any cost to STPI.  If the parties are unable to resolve their differences within sixty (60) days of STPI’s claim, then either party may refer the matter to an independent specialized firm of international reputation agreeable to both the parties for final analysis, which shall be a final resolution of such issue, binding on both parties hereto. If the PRODUCT and AG PRODUCT is determined to be in compliance or if there is a nonconformity with respect to such PRODUCT and AG PRODUCT but the nonconformity occurred after delivery by DOR, then STPI shall bear the cost of the independent laboratory testing and pay for the PRODUCT and AG PRODUCT in accordance with this AGREEMENT and DOR shall have no liability.  If the PRODUCT and AG PRODUCT is determined not to be in compliance, then DOR shall bear the cost of independent laboratory testing, and shall, at its election, either replace the rejected PRODUCT and AG PRODUCT at no cost to STPI, or credit STPI for the SUPPLY PRICE paid by STPI with respect to the defective PRODUCT and AG PRODUCT. STPI shall provide prompt assistance to DOR in connection with any recall including without limitation notification of the customers and recalling the PRODUCT and AG PRODUCT supplied to such customers, at DOR’s cost.  Each party shall act in good faith and shall cooperate with the other party, with any qualified independent third-party laboratory in connection with an investigation, and with the arbitrator, as to the existence of or source of nonconformity with respect to a batch of PRODUCT and AG PRODUCT supplied under this AGREEMENT.  In testing the batch of PRODUCT and AG PRODUCT, any independent third-party laboratory shall use analytical testing methods as agreed upon by the parties. This shall be the sole remedy for the resolution of any claims STPI or its AFFILIATES related to any defective or non conforming PRODUCT.  The provisions of this Article 8.8 shall not in any way limit DOR’s indemnification obligations under Article 13.2.

 

8.9

DOR undertakes to appoint at least one back up manufacturer. Should DOR expect to be unable, directly or indirectly, to timely and accurately supply STPI with STPI’s total requirement of the PRODUCT and AG PRODUCT, it will promptly inform STPI in advance and the parties will promptly convene to agree in good faith how best to proceed, including using alternate manufacturer/s to fulfill DOR’s obligation to supply PRODUCT and AG PRODUCT. This Article 8.9 is without prejudice for STPI to claim any and all damages resulting from DOR’s inability to timely and accurately fulfill its obligation to supply STPI with all STPI’s requirements of the PRODUCT and AG PRODUCT in the TERRITORY.

 

8.10

OTHER THAN AS SET FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES OF EITHER PARTY, BOTH EXPRESS AND IMPLIED, ARE HEREBY EXPRESSLY DISCLAIMED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE DRUG SUBSTANCE OR THE SERVICES PROVIDED HEREUNDER.  IN NO EVENT SHALL DOR OR STPI BE LIABLE FOR CONSEQUENTIAL DAMAGES, INCIDENTAL DAMAGES, LOST PROFITS, LOST PRODUCTS, PUNITIVE DAMAGES OR LOSS OF OPPORTUNITY.

 

8.11

DOR shall maintain true and accurate books, records, test and laboratory data, reports and all other information relating to manufacturing and packaging under this AGREEMENT, including all information required to be maintained by the specifications and all applicable laws.  Such information shall be maintained in forms, notebooks and records for a period as required under applicable laws and/or as outlined in the QUALITY ASSURANCE AGREEMENT.

 

 

9 -	CONSIDERATION

 

9.1	STPI shall pay to DOR the following amounts plus VAT, if applicable:

 

9.1.1

one million U.S. Dollars (U.S. $1,000,000) to be paid within thirty (30) days of receipt of a report, certified by DOR, stating that the first patient in the PHASE 3 TRIAL has been administered the PRODUCT; and

 

9.1.2

***** to be paid within thirty (30) days of receipt of a report from DOR showing that the PHASE 3 TRIAL has successfully achieved its primary endpoint consistent with the FDA’s Special Protocol Assessment (SPA) feedback in support of an NDA; and

 

9.1.3

*****  to be paid within thirty (30) days upon the cumulative NET SALES in the TERRITORY having achieved twenty-five million U.S. Dollars (U.S. $25,000,000); and

 

9.1.4

***** to be paid within thirty (30) days upon the NET SALES in the TERRITORY for any twelve (12) month period (i.e., any twelve (12) consecutive months) exceeding fifty million U.S. Dollars (U.S. $50,000,000).

 

 

 

9.2	Supply Price.

 

9.2.1

STPI shall pay DOR a certain SUPPLY PRICE, starting from the FIRST COMMERCIAL SALE of the PRODUCT and AG PRODUCT by STPI during the term of this AGREEMENT, as specified by the provisions of Appendix C attached hereto.

 

9.2.2

Upon the ninety (90) days prior to the date where DOR will be required to supply PRODUCT to STPI, DOR shall inform STPI of the amount of the FIXED COMPONENT of the SUPPLY PRICE.  DOR shall reasonably cooperate with any request by STPI to review DOR’s determination of the FIXED COMPONENT, but barring any clear error in calculation, the determination of DOR shall be conclusive.  DOR shall inform STPI of any adjustment to the FIXED COMPONENT at least thirty (30) days prior to making such adjustment.  DOR shall reasonably cooperate with any request by STPI to review DOR’s determination of the adjustment to FIXED COMPONENT, but barring any clear error in calculation, the determination of DOR shall be conclusive and STPI.

 

9.2.3

STPI shall keep accurate books and records setting forth the sales in unit and value, the selling prices, the NET SALES and the amount of SUPPLY PRICE payable to DOR hereunder, for each country of the TERRITORY with regard to the PRODUCT and AG PRODUCT sold. DOR, at its discretion, shall be permitted either: to have performed by an independent certified public accounting firm of nationally recognized standing selected by DOR and reasonably acceptable to STPI, at DOR’s expense, yearly audits of STPI records and books related to the PRODUCT and AG PRODUCT, provided such audits are reasonably conducted at STPI convenience and during STPI regular business hours.  DOR’s representative or agent will be required to execute a reasonable and commercially customary confidentiality agreement with STPI prior to commencing any audit. Such auditor shall report to DOR only on the accuracy of the information provided by STPI (without taking any copies of STPI records and books) and whether additional amounts are owed.  Such audits may be conducted for any calendar year ending not more than twenty-four (24) months prior to the date of each request. The right to audit with respect to any calendar year shall terminate three (3) years after the end of any such calendar year. In the event that a discrepancy arises between the SUPPLY PRICE paid to DOR and STPI records and books, STPI shall be given thirty (30) days from the receipt of the notice to either explain such discrepancy and/or remedy such discrepancy, as appropriate.  Further, in the event of a discrepancy of more than five percent (5%) between the amount owed and the actual amount received by DOR, STPI shall reimburse all the actual expenses and costs incurred by DOR in performing such audit.

 

9.2.4

The obligation to pay SUPPLY PRICE hereunder shall be imposed only once with respect to each unit of the PRODUCT and AG PRODUCT.  No payments shall accrue on the sales of STPI to its AFFILIATED COMPANIES or sublicensees (if permitted) or distributors or agents as well as on any transactions between such entities.  Payments shall accrue only on sales to unrelated third parties in arm’s length transactions.

 

9.2.5

Any taxes (other than value added or income  taxes) STPI is required by the local authorities to pay or withhold on behalf of DOR with respect to the money payable to DOR under this AGREEMENT shall be deducted from the amount of such payments, provided, however, that with regard to any such deduction STPI shall give DOR such assistance as may be necessary to enable or assist DOR to claim exception therefore (under US or other applicable laws as well as any applicable treaties or conventions) and shall give DOR proper evidence as to payment of the tax.  Any other taxes due in the TERRITORY and arising out of or in connection with STPI exercise of the rights granted herein shall be borne by STPI.  STPI shall not be responsible for paying DOR’s income tax.

 

9.3

In the event of GENERIC COMPETITION in any country of the TERRITORY, the SUPPLY PRICE due in said country pursuant to Appendix C hereof shall be reduced (and may be subsequently increased, not to exceed the SUPPLY PRICE agreed to as of the date hereof) from time to time by the same percentage of the decrease (and may be subsequently increased, not to exceed the SUPPLY PRICE agreed to as of the date hereof) in the NET SALES during any three (3) month rolling period, provided, however, that in no event shall the SUPPLY PRICE be reduced to below ***** of the FULLY BURDENED MANUFACTURING COST.  Such reduction/s shall commence with the beginning of the next month following STPI’s written notification to DOR.

 

9.4

In the event it is necessary due to the claim of a third party or a court order to obtain a license from any unaffiliated third party under any patent or other intellectual property right having claims that the APPROVED PRODUCT that is currently subject to the PHASE 3 TRIAL or its use, sale or manufacture infringes, DOR shall have the sole and exclusive right to negotiate a license to such third party intellectual property.  If after six (6) months (or one (1) month if there is an injunction in place), DOR is unable to secure a license or other settlement, then STPI shall have the right to secure such a license or obtain other settlement provided that such terms are commercially reasonable within the applicable industry.  In the event that STPI is obligated to pay a royalty due to such infringement to such unaffiliated third party or parties in any country in order to COMMERCIALIZE the APPROVED PRODUCT in the TERRITORY in the FIELD, then STPI shall have the right to deduct the amount of such royalties which STPI pays to such unaffiliated party or parties for such product, in such country in a calendar quarter, from the PERCENTAGE COMPONENT of the SUPPLY PRICE to be paid to DOR as set forth in Appendix C for such PRODUCT in such country in a calendar quarter; provided, however, that in no event shall the PERCENTAGE COMPONENT of the SUPPLY PRICE for any PRODUCT payable hereunder to DOR be less than fifty percent (50%) of the amounts payable to DOR pursuant to Appendix C immediately prior to the initiation of STPI’s obligation to pay such third party royalty.  This provision shall also apply to any other APPROVED PRODUCT which is mutually agreed by the parties to be COMMERCIALIZED by STPI.

 

9.5

Without limiting the generality of the foregoing, DOR shall remain responsible for any royalty obligations due to third parties under the PATENT RIGHTS and/or the KNOW-HOW and/or the TRADEMARK which have been licensed to STPI hereunder. DOR will not be entitled to add such royalties due to third parties to the SUPPLY PRICE.

 

10 -	PATENT RIGHTS

 

10.1	For the entire term of this AGREEMENT, DOR shall prosecute and maintain the PATENT RIGHTS at its own expense.

 

10.2

Each party shall advise the other promptly upon its becoming aware of any third party infringement of the PATENT RIGHTS. After discussing its intentions with STPI, DOR may at its option take such action as is required to restrain such infringement, STPI having the right to cooperate in its attempt to restrain such infringement. STPI may be represented by counsel of its own choice, at its own expense at any suit or proceeding brought to restrain such infringement. If, however, within forty-five (45) days of the notice of a third party infringement, DOR fails to institute an infringement suit that STPI feels is reasonably required, STPI shall have the right at its own discretion to institute an action for infringement of any of the claim or claims of  the  PATENT RIGHTS in question and DOR agrees to use DILIGENT EFFORTS under the MCDONALD LICENSE to protect STPI’s rights set forth herein. After MCDONALD has been paid any and all amounts owed under Section 9 of the MCDONALD LICENSE, to the extent applicable, and after both parties have been reimbursed for their expenses in bringing such suit or proceeding, any further recovery obtained as a result of such action, whether by judgment, award, decree or settlement, shall be split as follows: (i) if DOR brings the action, then DOR retains 65% and STPI retains 35% and (ii) if STPI brings the action, then DOR retains 35% and STPI retains 65%.

 

10.3	Should any settlement or judicial finding which is reviewable by a higher authority arise as a result of such action, then STPI and DOR shall reasonably consult before accepting any settlement or judicial finding which is reviewable by a higher authority.

 

10.4

MCDONALD has certain rights to participate in any action for infringement and other rights as set forth in Section 9 of the MCDONALD LICENSE and to the extent applicable, the rights of the parties in respect thereof are subject to such rights of MCDONALD as set forth in the MCDONALD LICENSE as if fully set forth herein.

 

11 -	REPRESENTATIONS AND WARRANTIES

 

11.1

Each of DOR and STPI warrant and represent to the other that, (i) it has the full corporate right and authority to enter into the AGREEMENT, (ii) except as specifically provided in Section 2B(iv) of the MCDONALD LICENSE, the restrictions of which MCDONALD has waived, no contractual impediment conflicts, and during the term of this AGREEMENT it will not permit to exist any contractual impediment that would conflict, its ability to perform the terms and conditions imposed on it by this AGREEMENT, (iii) the execution, delivery and performance of this AGREEMENT by either party have been duly authorized and approved by all necessary corporate action, (iv) the AGREEMENT is binding upon and enforceable against either party in accordance with its terms (subject to bankruptcy and similar laws affecting the rights of creditors generally), and (v) to the knowledge of such party, as of the EFFECTIVE DATE (without undertaking any special investigation), there is no claim, action, suit, proceeding or investigation pending or threatened against or affecting the transaction contemplated hereby.

 

11.2

DOR warrants and represents that, to the best of its knowledge, based on the current best knowledge of its officers, after inquiry of the attorneys of DOR, it is not aware of any third party patents which would be infringed by the import, manufacture, development, use, sale, or offer for sale of the PRODUCT or that has been asserted to cover the import, manufacture, development, use, sale, or offer for sale of the PRODUCT. DOR further represents and warrants that, to its knowledge, based on the current best knowledge of its officers, after inquiry of the attorneys of DOR, it is not aware that any third party is infringing the PATENT RIGHTS.

 

11.3

DOR warrants and represents that all of its PATENT RIGHTS claiming the SUBSTANCE and/or the PRODUCT have been disclosed to STPI and are listed in Appendix B of this AGREEMENT. DOR warrants and represents that it owns or is in CONTROL of all right, title and interest in and to the PATENT RIGHTS and, and to the best of its knowledge, based on the current knowledge of its officers, after inquiry of the patent attorneys of DOR, the KNOW-HOW, in the sense of being able to convey to STPI, in accordance with this AGREEMENT, the exclusive rights hereunder in the FIELD in the TERRITORY, to the extent conveyed. Without limiting the generality of the foregoing (subject to the right of the U.S. Government to use any licensed patent developed using government funding pursuant to the MCDONALD LICENSE), DOR represents and warrants that none of the PATENT RIGHTS or KNOW-HOW have been pledged, assigned or otherwise conveyed, in whole or in part, to a third party.

 

11.4

DOR warrants and represents that the PATENT RIGHTS constitute all of the patents and patent applications owned or CONTROLLED by DOR as of the EFFECTIVE DATE that are necessary or are useful to use or COMMERCIALIZE the PRODUCT in the TERRITORY (as the PRODUCT is known to DOR as of the EFFECTIVE DATE, and if such PRODUCT were to be COMMERCIALIZED as of the EFFECTIVE DATE).

 

11.5

DOR warrants and represents that, to its knowledge, all the PATENT RIGHTS listed on Appendix B are in full force and effect and have been maintained to date, and all fees required to be paid by DOR in order to maintain the PATENT RIGHTS have been paid to date, and none such PATENT RIGHT has been abandoned or cancelled for failure to prosecute or maintain it.

 

11.6

DOR warrants and represents that it has made available to STPI copies of all material correspondence with the FDA related to the PRODUCT in DOR’s CONTROL.  DOR further represents and warrants that none of the PATENT RIGHTS applicable to the PRODUCT is currently involved in any interference, reissue, reexamination proceeding, or litigation, and neither DOR nor any of its AFFILIATES has received any written notice from any person of such actual or threatened proceeding.

 

11.7

DOR warrants and represents that DOR has used its DILIGENT EFFORTS to make  available to or provide STPI with copies of all information in DOR’s CONTROL regarding the PRODUCT in the TERRITORY, the PATENT RIGHTS and the KNOW-HOW which could reasonably be expected to be material to assessing the commercial potential for the PRODUCT, the ability to timely gain regulatory approval of the PRODUCT, and/or the risks of infringing third party intellectual property through use or COMMERCIALIZATION of the PRODUCT.

 

11.8

To DOR’s knowledge, the Data Room maintained by DOR and made available to STPI contains copies of all material information in the possession or CONTROL of DOR relating to quality, toxicity, safety and/or efficacy which would materially impair the utility and/or safety of the PRODUCT or the development, manufacture and COMMERCIALIZATION of the PRODUCT in the TERRITORY.

 

11.9

Except for MCDONALD, whose inventions relate to the PATENT RIGHTS, DOR warrants and represents that all current, former and future employees and consultants of DOR and its AFFILIATES who are, have been or will be substantively involved in the design, review, evaluation or development of the PATENT RIGHTS, the KNOW-HOW, the SUBSTANCE or the PRODUCT have executed (or with respect to future employees or consultants will execute) written contracts or are otherwise obligated to protect the confidential information of STPI, DOR, and of any third party received through their position with DOR, and to vest in DOR or its AFFILIATES exclusive ownership of the PATENT RIGHTS and KNOW-HOW they have invented or developed.

 

11.10

DOR represents and warrants that at all times during the term of this AGREEMENT, it will, and it will require its distributors and if permitted, sublicensees to, obtain, maintain and comply with all licenses, permits and authorizations necessary to it to complete and timely perform its obligations under this AGREEMENT, which are required under any applicable statutes, laws, ordinances, rules and regulations of the United States as well as those of all applicable foreign governmental bodies, agencies and subdivisions, having, asserting or claiming jurisdiction over DOR or any of such distributors or sublicensee.  DOR understands and acknowledges that the transfer of certain commodities and technical data is subject to United States laws and regulations controlling the export of such commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce.  These laws and regulations, among other things, prohibit or require a license for the export of certain types of technical data to certain specified countries.  DOR hereby agrees and gives written assurance that it will comply with all United States laws and regulations controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by DOR or its AFFILIATES, distributors or sublicensees (if permitted), and that DOR will defend and hold STPI harmless if of any legal action of any nature occasioned by such violation).

 

11.11

STPI represents and warrants that at all times during the term of this AGREEMENT, it will, and it will require its distributors and if permitted, sublicensees will obtain, maintain and comply with all licenses, permits and authorizations necessary to it to complete and timely perform its obligations under this AGREEMENT, which are required under any applicable statutes, laws, ordinances, rules and regulations of the United States as well as those of all applicable foreign governmental bodies, agencies and subdivisions, having, asserting or claiming jurisdiction over STPI or any of such distributors or sublicensee.  STPI understands and acknowledges that the transfer of certain commodities and technical data is subject to United States laws and regulations controlling the export of such commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce.  These laws and regulations, among other things, prohibit or require a license for the export of certain types of technical data to certain specified countries.  STPI hereby agrees and gives written assurance that it will comply with all United States laws and regulations controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by STPI or its AFFILIATES, distributors or sublicensees (if permitted), and that STPI will defend and hold DOR harmless if of any legal action of any nature occasioned by such violation.   STPI agrees not to repackage any PRODUCT or add, modify or remove any labels on or product inserts in any PRODUCT, except as authorized by the JOINT COMMERCIALIZATION COMMITTEE.

 

11.12

DOR represents and warrants that it has the rights to grant the sublicense and other rights granted to STPI herein.

 

12 -	FORCE MAJEURE

 

 

13 -	LIABILITY AND INDEMNIFICATION

 

13.1

STPI hereby agrees to save, defend, indemnify and hold DOR and its officers, directors, employees, independent contractors, agents, and assigns, harmless from and against any and all third party suits, claims, actions, demands, liabilities, expenses or loss (including reasonable attorneys’ fees) resulting from:

 

13.1.1

STPI’s handling, storage, distributing, marketing or selling of the PRODUCT and AG PRODUCT;

 

13.1.2

STPI’s negligence or willful misconduct in its performance pursuant to this AGREEMENT;

 

13.1.3

STPI’s material breach of any of its covenants, warranties and representations under this AGREEMENT; or

 

13.1.4

STPI’s violation of any applicable law or regulations.

 

 

13.2

DOR hereby agrees to save, defend, indemnify and hold STPI and its AFFILIATES, and their respective officers, directors, employees, independent contractors, agents, and assigns, harmless from and against any and all third party suits, claims, actions, demands, liabilities, expenses or loss (including reasonable attorneys’ fees) resulting from:

 

13.2.1

DOR’s (itself or pursuant to a contract with third party) development, manufacturing, storage or handling of SUBSTANCE manufactured by or on behalf of DOR and registration, development manufacturing, storage or handling of the PRODUCT and AG PRODUCT manufactured by or on behalf of DOR;

 

13.2.2

DOR’s negligence or willful misconduct in its performance pursuant to this AGREEMENT or the MCDONALD LICENSE;

 

13.2.3

DOR’s material breach of any of its covenants, warranties and representations made under this AGREEMENT or the MCDONALD LICENSE; or

 

13.2.4

DOR’s violation of any applicable law or regulations.

 

 

13.3

STPI and DOR shall promptly notify each other of any claims or suits as to which this indemnification applies. Neither STPI nor DOR shall agree to any settlement terms with respect to such claim or suit without the prior written consent of the other, such consent not to be unreasonably withheld.  STPI and DOR may, at their own expense, retain their own counsel in connection with such claim or suit.

 

13.4

If STPI or one of its AFFILIATES brings an action or proceeding challenging the validity or enforceability of any PATENT RIGHTS, then STPI shall reimburse DOR for any reasonable and documented attorneys’ fees, costs and expenses incurred by DOR (including any reimbursement under the MCDONALD LICENSE) in connection with such action or proceeding; provided, however, that DOR''s right to receive reimbursement from STPI pursuant to this Article 13.4 shall be waived upon exercise of DOR’s termination right pursuant to Article 15.3.

 

13.5

EXCEPT IN RESPECT OF THIRD PARTY CLAIMS, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL LOSSES OR DAMAGES, INCLUDING LOSS OF PROFITS OR REVENUE, INCURRED BY THE OTHER PARTY OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

13.6	Each party shall maintain product liability insurance as is usual customary for this industry and type of PRODUCT and AG PRODUCT.

 

14 -	TERM AND RULES POST EXPIRATION

 

14.1

This AGREEMENT shall enter into full force and effect at the EFFECTIVE DATE. This AGREEMENT shall remain in force on a country-by-country basis until the later of the two following dates (the “INITIAL TERM”): (i) ten (10) years from the date of the FIRST COMMERCIAL SALE of the PRODUCT by STPI in such country of the TERRITORY; or (ii) until the expiration of the last to expire of the PATENT RIGHTS in such country of the TERRITORY having at least one VALID CLAIM covering the PRODUCT, its use or manufacture, to the extent such VALID CLAIM could be enforced against STPI’s activities if not for the rights granted hereunder.

 

14.2	Upon the INITIAL TERM and on a country-by-country basis this AGREEMENT shall be automatically renewed for periods of five (5) years each provided that during such renewal period/s:

 

14.2.1

STPI has the right to terminate for convenience this AGREEMENT after the INITIAL TERM upon six (6) months prior written notice to DOR;

 

14.2.2

DOR has the right to terminate for convenience this AGREEMENT after the INITIAL TERM upon eighteen (18) months prior written notice to STPI.  In this case DOR shall transfer free of charge to STPI or its designee the MARKETING AUTHORIZATIONS and all relevant data and KNOW-HOW necessary to manufacture and COMMERCIALIZE the PRODUCT in the TERRITORY and shall grant to STPI a royalty-free, fully paid up, perpetual and irrevocable license, with the right to sublicense, to the TRADEMARK and the KNOW-HOW.  Termination of this AGREEMENT shall be effective only after such transfers and license grant have been executed.

 

15 -	TERMINATION AND RULES POST TERMINATION

 

15.1

In the event either party shall be in breach of any material obligation hereunder, the non breaching party may give written notice to the other party specifying the claimed particulars of such breach, and in the event such material breach is not cured, or effective steps to cure such material breach have not been initiated or are not thereafter diligently pursued, within sixty (60) days following the date of such written notification, the non breaching party shall have the right thereafter to terminate the AGREEMENT by giving thirty (30) days prior written notice to the other party to such effect.

 

15.2

Each party (the “INSOLVENT PARTY”) shall promptly notify the other party (the “SOLVENT PARTY”) in writing upon the initiation of any proceeding in bankruptcy (voluntary or involuntary), reorganization, dissolution, liquidation or arrangement for the appointment of a receiver or trustee to take possession of the assets of the INSOLVENT PARTY or similar proceeding under the law for release of creditors by or against the INSOLVENT PARTY or if the INSOLVENT PARTY shall make a general assignment for the benefit of its creditors.  If any of the applicable circumstances described above, besides a voluntary bankruptcy petition, shall have continued for one hundred twenty (120) days undismissed, unstayed, unbonded and undischarged, the SOLVENT PARTY may terminate this AGREEMENT upon written notice to the INSOLVENT PARTY upon notice of the circumstances referenced above; provided, however, if the INSOLVENT PARTY provides for the cure of all of its defaults under this AGREEMENT (if any) and provides adequate assurance of its future performance of its obligations to the SOLVENT PARTY’s reasonable satisfaction, then the SOLVENT PARTY shall not have the right to terminate this AGREEMENT pursuant to this Article 15.2.  If the INSOLVENT PARTY shall initiate any voluntary bankruptcy proceeding, then the SOLVENT PARTY may terminate this AGREEMENT upon written notice to the INSOLVENT PARTY.  All licenses and rights to licenses granted under or pursuant to this AGREEMENT and the Supply Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “CODE”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the CODE.  STPI, as the licensee of such rights under this AGREEMENT, shall retain and may fully exercise all of its rights and elections under the CODE.  The foregoing provisions of this Article 15.2 are without prejudice to any rights STPI may have arising under the CODE or other applicable law.

 

15.3	DOR shall have the right to terminate this Agreement in the event that STPI, directly or indirectly, challenges or assists any third party in the challenge of the validity of any of the PATENT RIGHTS.

 

15.4

Upon any termination of this AGREEMENT other than for breach by STPI, STPI shall be allowed to process and sell the inventory of PRODUCT at its disposal for a period not to exceed three (3) months following the date of termination, subject to the payment of the amounts owed hereunder to DOR and continued compliance with the terms of this AGREEMENT.  Upon termination of this AGREEMENT by STPI in accordance with Article 14.2.1 or by DOR in accordance with this Article 15, STPI shall destroy all of DOR’s CONFIDENTIAL INFORMATION received hereunder.  After the execution of this AGREEMENT, DOR will use commercially reasonable efforts (which shall exclude the obligation to pay any additional monies) to amend the MCDONALD LICENSE to extend the post termination sale period from three (3) months to one (1) year.

 

15.5	The right of either party to terminate this AGREEMENT as provided hereinabove shall not be affected in any way by its waiver of or failure to take actions with respect to any previous default.

 

15.6

Upon any early termination of this AGREEMENT, RECEIVING PARTY shall return to DISCLOSING PARTY all of its CONFIDENTIAL INFORMATION and transfer to DISCLOSING PARTY all reports, records, customer lists, regulatory correspondence and other materials in RECEIVING PARTY’s or its AFFILIATES’ possession or control relating to the pre-clinical and clinical development, APPROVAL, manufacture, distribution and sale of PRODUCTS, including without limitation the safety database and such reports, records, regulatory correspondence and other materials related to the COMMERCIALIZATION of the PRODUCT, if any.  In addition all sublicenses (if any) or distributorships shall terminate provided however that at DOR’s request, STPI shall use its commercially reasonable efforts to assign to DOR any third party distributor contract relating to such PRODUCTS to which STPI or any of its AFFILIATES is a party (or the applicable provisions thereof, as the case may be).  If STPI terminates this AGREEMENT other than for cause or if this AGREEMENT is terminated by DOR for cause or pursuant to Article 15.3, STPI and its AFFILIATE and distributors will immediately (i) cease any sale of PRODUCT and AG PRODUCT and destroy or return all PRODUCT and AG PRODUCT and (ii) provide an accurate and up to date list of purchasers of the PRODUCT and AG PRODUCT along with quantities and purchase price.  STPI shall provide evidence reasonably satisfactory to DOR regarding its compliance with the foregoing sentence.

 

15.7

The termination or expiration of this AGREEMENT for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either party prior to such termination or expiration, including any damages arising from any breach hereunder.  Such termination or expiration shall not relieve either party from obligations which are expressly indicated to survive termination or expiration of this AGREEMENT.

 

16 -	MISCELLANEOUS

 

16.1	Modifications.  No amendments, changes, modifications or alterations of the terms and conditions of this AGREEMENT shall be binding upon either party hereto unless in writing and signed by both parties.

 

16.2	Captions.  All titles and captions in this AGREEMENT are for convenience only and shall not be interpreted as having any substantive meaning.

 

16.3

Assignment.  Unless consent in writing is first obtained from the other party, this AGREEMENT and the rights granted herein shall not be assignable by either party hereto, except to a successor to all or substantially all of its business.  Any attempted assignment without consent shall be void. Any permitted assignee shall assume all obligations of its assignor under the AGREEMENT. Notwithstanding the foregoing, either party may assign this AGREEMENT to any of its AFFILIATES without the consent of the other party provided that (i) the assignor party shall be responsible for the performance by the assignee of any of its obligations provided for herein and severally and jointly liable with such assignee for the failure to perform its obligations provided for herein, including minimum royalty obligations and (ii) prior written notice of such assignment is given to the other party.

 

16.4

Survivability.  Expiration or termination of this AGREEMENT shall not relieve the parties of any obligation accruing prior to such expiration or termination. Without limiting the foregoing, the obligations pursuant to Article 1 (Definitions) (to the extent applicable), Article 3.3 (Confidentiality), Article 3.4 (Confidentiality), Article 3.5 (Notification of Serious Adverse Events and Safety Information), Article 3.6 (Written Publications), Article 8.10 (Disclaimer of Warranties), Article 9.1 (Milestone Payments), Article 9.2 (Supply Price), Article 13 (Liability and Indemnification), Article 14 (Term and Rules Post Expiration), Article 15 (Termination and Rules Post Termination), Article 16 (Miscellaneous), and Article 17 (Law, Dispute Resolution and Jurisdiction) shall survive termination of this AGREEMENT.

 

16.5	Entire Understanding.  This AGREEMENT and its Appendixes constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all previous agreements and representations, whether written or oral.

 

16.6	Notices.  Any notice required to be given hereunder shall be considered properly given if sent by registered air-mail, telecopier, or by personal courier delivery to the respective address of each party as follows:

 

 

 

 

 

 

 

 

 

 

16.7

Violation.  If any of the provisions of this AGREEMENT are held to be void or unenforceable with regard to any particular country or all countries of the TERRITORY, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions which will achieve as far as possible the economic business intentions of the parties.

 

16.8

Press Releases.  All press releases regarding this AGREEMENT shall be jointly planned and coordinated in detail by and between DOR and STPI. Each party agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence of this AGREEMENT or any information relating to this AGREEMENT without the prior written consent of the other party; provided, however, that neither party will be prevented from complying with any duty of disclosure it may have pursuant to law or governmental regulation. The parties shall consult with each other reasonably and in good faith and agree with respect to the text and timing of such press releases prior to the issuance thereof, provided that a party may not unreasonably withhold consent to or delay such releases.

 

16.9	Counterparts.  This AGREEMENT may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

16.10

No Waiver.  The waiver of and relief from any breach or non-fulfillment of any term and condition of this AGREEMENT does not constitute a waiver of or relief from any other breach or non-fulfillment of that or any other term and condition.