**EXHIBIT 10.2****LICENSE AND DISTRIBUTION AGREEMENT****THIS LICENSE AND DISTRIBUTION AGREEMENT**is entered into as of the 27 day of September 2006, by andbetween **VALERA PHARMACEUTICALS, INC.,**a corporation incorporated under the laws of the state ofDelaware with its principal place of business located at 7 Clarke Drive, Cranbury, New Jersey08512-3617 USA (“***Valera***”), and **SPEPHARM HOLDINGB.V.**, a corporation incorporated under the laws ofthe Netherlands with its principal place ofbusiness located in Amsterdam, the Netherlands(“***Spepharm***”).**BACKGROUND**WHEREAS, Spepharm has been organized for the purpose of serving as a distributor of specialtypharmaceutical products throughout Europe;WHEREAS, Valera has developed and is the sole owner of certain patent rights and other intellectualproperty relating to certain Products;WHEREAS, Valera wishes to appoint Spepharm as the exclusive licensee and distributor of theProducts in the Territory (as defined below) for use in the same indications for which Valera ownsor controls an approval from the United States Food and Drug Administration or similar agency of aforeign government, the whole in accordance with the terms and conditions set forth in thisAgreement;WHEREAS, Spepharm desires Valera to supply Spepharm with the Products on an exclusive basis in theTerritory prior to Regulatory Approval (as defined below), and following receipt of RegulatoryApproval, for distribution and sale in the Territory for use in the indications described above,the whole in accordance with the terms and conditions set forth in this Agreement.**TERMS**NOW, THEREFORE, in consideration of the respective covenants, agreements, representations,warranties and indemnities contained in this Agreement and for other good and valuableconsideration, Spepharm and Valera hereby covenant and agree as follows:**Article 1**– **Definitions and Interpretation**1.1 **Definitions.**For the purposes of this Agreement or any notice, consent, authorizationor other communication required or permitted to be given under this Agreement, the followingexpressions shall have the following meanings, respectively, unless the context otherwise requires:(a) “***Affiliate***” shall mean any Person which directly or indirectly controls, iscontrolled by, or is under common control with another Person; provided that “control” shall meanownership as to more than fifty percent (50%) of the outstanding voting equity securities ofanother Person or the power to direct decisions of another Person including, without limitation,the power to direct management and policies of another Person, whether by reason of ownership, bycontract or otherwise.(b) *“****Agreement****”*shall mean this License and Distribution Agreement, as amended from timeto time.(c) “***Business Day***” shall mean any day other than a Saturday, Sunday or other day on whichthe branches of the Federal Reserve Bank with jurisdiction over the then-current principal place ofbusiness of Valera are not open for business.(d) “***Calendar Month***” shall mean each calendar month of each year during the term of thisAgreement.(e) “***Calendar Quarter***” shall mean the periods from January 1st to March31st, April 1st to June 30th, July 1st to September30th and October 1st to December 31st in a given year.(f) “***Calendar Year***” shall mean the period from January 1st to December31st in a given year.(g) “***CMC information***” shall mean the chemistry, manufacturing, and control informationfiled by Valera from time to time with the FDA with respect to a Product.
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(h) “***Commercial Sale***” means any sale or distribution of a Productby Spepharm or itsAffiliates or sublicensees to a Third Party, other than distribution in connection with clinicaltrials of a Product conducted by Spepharm. For the avoidance of doubt, the sale or distribution ofa Product between or among any of Spepharm or its Affiliates or sublicensees shall not beconsidered a Commercial Sale.(i) “***Competing Product***” shall be as defined in Section 3.5.(j) “***Confidential Information***” shall be as defined in Section 12.1.(k) “***Development Plan***” shall have the meaning set forth in Section 2.3.(l) “***Dollar***” and the symbol “$” shall mean lawful money of the United States.(m) “***Effective Date***” shall mean the date first written above.(n) “***Event of Force Majeure***” shall have the meaning set forth in Section 14.1.(o) “***FDA***” means the United States Food and Drug Administration and any successor thereto.(p) “***Forecast***” shall be as defined in Section 6.3.(q) “***GMPs***” shall mean then-current Good Manufacturing Practices as required under therules and regulations of the FDA.(r) “***Governmental Body***” shall mean (i) any national, federal, provincial, state,municipal or other government or body with jurisdiction over all or any part of the Territory, (ii)any subdivision, ministry, department, secretariat, bureau, agency, commission, board,instrumentality or authority of any of the foregoing governments or bodies, (iii) anyquasigovernmental or private body exercising any regulatory, expropriation or taxing authorityunder or for the account of any of the foregoing governments or bodies, or (iv) any domestic orforeign judicial, quasi-judicial, arbitration or administrative court, grand jury, tribunal,commission, board or panel of any of the foregoing governments or bodies.(s) “***Implant***” means Valera’s proprietary histrelin implants currently marketed or to bemarketed in the United States under the trademark Vantas® or Supprelin®.(t) “***Implantation Device***” means the TROCAR device that is used to insert an Implant intoa human body.(u) “***Improvements***” shall mean any re-formulations, lineextensions or other advances in,or modifications or improvements to, a Product for use in an Indication.(v) “***Indemnified Party***” shall be as defined in Section 10.3.(w) “***Indemnifying Party***” shall be as defined in Section 10.3.(x) “***Indication***” shall mean an indication for which an Implant is approved for marketingand sale, the approval of which issued by the FDA or similar agency of a foreign government. As ofthe Effective Date, the only indication for which an Implant has been approved for marketing andsale in the United States is the treatment of hormone responsive prostate cancer.(y) “***Labels***” shall mean (i) all labels and other written, printed, or graphic matter uponthe Product or any packaging, container or wrapper utilized with the Product, in each case whensold for use in the United States and (ii) any written material accompanying the Product, includingwithout limitation, any package inserts, in each case when sold for use in theUnited States.(z) “***Laws***” shall mean:(i) all constitutions, treaties, laws, statutes, codes, ordinances, orders, decrees,rules, regulations, and municipal by-laws, whether domestic, foreign or international, includingany such constitutions, etc. of any Governmental Body;(ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards ofany Governmental Body; and
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(iii) all policies, practices and guidelines of any Governmental Body, in each casebinding on or affecting the Party or Person referred to in the context in which such word is used;and “Law” shall mean any one of them.(aa) “***Losses***” shall mean liabilities, damages, costs or expenses, including reasonablefees and expenses of attorneys and other professionals, as well as court costs.(bb) “***Marketing Approval Application***” shall mean an application or registration filedwith a Regulatory Authority seeking the approval to market, distribute and sell the Product for anIndication in the jurisdiction controlled by such Regulatory Authority.(cc) “***Marketing Plan***” shall have the meaning set forth in Section3.9.(dd) “***Material Breach***” shall mean any breach of the terms of this Agreement of such anature as to have a material effect on the non-breaching Party.(ee) **“*****Minimum Net Sales*****”**shall mean for a specified Calendar