LICENSE AND DISTRIBUTION AGREEMENT

EXHIBIT 10.2

LICENSE AND DISTRIBUTION AGREEMENT

THIS LICENSE AND DISTRIBUTION AGREEMENT is entered into as of the 27 day of September 2006, by and between VALERA PHARMACEUTICALS, INC., a corporation incorporated under the laws of the state of Delaware with its principal place of business located at 7 Clarke Drive, Cranbury, New Jersey 08512-3617 USA (“ Valera ”), and SPEPHARM HOLDINGB.V. , a corporation incorporated under the laws of the 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 specialty pharmaceutical products throughout Europe;

WHEREAS, Valera has developed and is the sole owner of certain patent rights and other intellectual property relating to certain Products;

WHEREAS, Valera wishes to appoint Spepharm as the exclusive licensee and distributor of the Products in the Territory (as defined below) for use in the same indications for which Valera owns or controls an approval from the United States Food and Drug Administration or similar agency of a foreign government, the whole in accordance with the terms and conditions set forth in this Agreement;

WHEREAS, Spepharm desires Valera to supply Spepharm with the Products on an exclusive basis in the Territory prior to Regulatory Approval (as defined below), and following receipt of Regulatory Approval, 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 valuable consideration, 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, authorization or other communication required or permitted to be given under this Agreement, the following expressions shall have the following meanings, respectively, unless the context otherwise requires:

(a) “ Affiliate ” shall mean any Person which directly or indirectly controls, is controlled by, or is under common control with another Person; provided that “control” shall mean ownership as to more than fifty percent (50%) of the outstanding voting equity securities of another 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, by contract or otherwise.

(b) “ Agreement ” shall mean this License and Distribution Agreement, as amended from time to time.

(c) “ Business Day ” shall mean any day other than a Saturday, Sunday or other day on which the branches of the Federal Reserve Bank with jurisdiction over the then-current principal place of business of Valera are not open for business.

(d) “ Calendar Month ” shall mean each calendar month of each year during the term of this Agreement.

(e) “ Calendar Quarter ” shall mean the periods from January 1st to March 31st, April 1st to June 30th, July 1st to September 30th and October 1st to December 31st in a given year.

(f) “ Calendar Year ” shall mean the period from January 1st to December 31st in a given year.

(g) “ CMC information ” shall mean the chemistry, manufacturing, and control information filed by Valera from time to time with the FDA with respect to a Product.

(h) “ Commercial Sale ” means any sale or distribution of a Productby Spepharm or its Affiliates or sublicensees to a Third Party, other than distribution in connection with clinical trials of a Product conducted by Spepharm. For the avoidance of doubt, the sale or distribution of a Product between or among any of Spepharm or its Affiliates or sublicensees shall not be considered 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 the rules 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) any quasigovernmental or private body exercising any regulatory, expropriation or taxing authority under or for the account of any of the foregoing governments or bodies, or (iv) any domestic or foreign 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 be marketed in the United States under the trademark Vantas® or Supprelin®.

(t) “ Implantation Device ” means the TROCAR device that is used to insert an Implant into a 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 marketing and sale, the approval of which issued by the FDA or similar agency of a foreign government. As of the Effective Date, the only indication for which an Implant has been approved for marketing and sale 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 upon the Product or any packaging, container or wrapper utilized with the Product, in each case when sold for use in the United States and (ii) any written material accompanying the Product, including without 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, including any such constitutions, etc. of any Governmental Body;

(ii) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any Governmental Body; and

(iii) all policies, practices and guidelines of any Governmental Body, in each case binding 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 reasonable fees and expenses of attorneys and other professionals, as well as court costs.

(bb) “ Marketing Approval Application ” shall mean an application or registration filed with a Regulatory Authority seeking the approval to market, distribute and sell the Product for an Indication in the jurisdiction controlled by such Regulatory Authority.

(cc) “ Marketing Plan ” shall have the meaning set forth in Section 3.9.

(dd) “ Material Breach ” shall mean any breach of the terms of this Agreement of such a nature as to have a material effect on the non-breaching Party.

(ee) “ Minimum Net Sales ” shall mean for a specified Calendar
Year the Minimum Unit Quantities (as defined in Schedule 1) of the Products as set forth in Schedule 1, multiplied by the Average Net Selling Price for the respective Calendar Year. The Average Net Selling Price shall be calculated by dividing the Net Sales of the relevant Calendar Year by the number of Units sold in such Calendar Year. The Minimum Unit Quantities set forth in Schedule 1 are based on assumed dates for Regulatory Approvals as set forth in Schedule 1. If Regulatory Approvals are not granted by the specified dates, the parties shall negotiate in good faith an adjustment of the Minimum Unit Quantities for purposes of determining Minimum Net Sales, unless such delay is caused by Spepharm. The parties shall also be obligated to negotiate in good faith an adjustment of the Minimum Unit Quantities for purposes of determining Minimum Net Sales, if (i) the launch of a Product is delayed because Spepharm cannot use the trademark Vantas® or Supprelin®, as applicable, or a reasonable alternative trademark provided by Valera in reasonable time prior to such launch, in any country of the Territory or (ii) following the launch of the respective Product, Spepharm’s use of the trademark Vantas® or Supprelin®, or any alternative trademark that may have been used by Spepharm for such Product at the time of launch, as applicable, is contested by a third party in any country of the Territory and as a result Spepharm cannot use such trademark in such country.

(ff) “ Net Sales ” shall mean the gross amount invoiced by Spepharm or its Affiliates or sublicensees with respect to the Commercial Sale of the Products in the Territory, less the aggregate of: (i) customers’ returns for Products that fail to comply with the warranties set forth in Section 8.1; (ii) amounts paid for freight, transport and delivery, including insurance, for shipping from Spepharm’s or its Affiliates’ or sublicensees’ or their respective designees’ facilities to a customer (but only to the extent of the actual cost of such freight, transport and delivery charges); (iii) any sales tax, value added tax, goods and services tax or any other tax that may be imposed on the sale of the Product, which taxes are included in gross amount invoiced by Spepharm and its Affiliates or sublicensees; (iv) amounts actually repaid or credited for retroactive price reductions; and (v) rebates, including those paid or payable pursuant to governmental regulations or agreements with governmental entities.

(gg) “ Parties ” shall mean Spepharm and Valera, collectively.

(hh) “ Party ” shall mean either Valera or Spepharm, as the context requires.

(ii) “ Person ” shall mean an individual, corporation, limited liability company, co-operative, partnership, organization or any similar entity.

(jj) “ Plan ” shall be as defined in Section 2.3.

(kk) “ Product ” shall mean all dosage strengths and forms of either of the Implants in final finished form along with the Implantation Device, together with all Labels and any and all Improvements.

(ll) “ Promotional Materials ” shall mean all promotional materials, detail aids and pieces, journal ads, films, artwork and graphics, and any other marketing literature and information relating to the marketing, distribution or sale of a Product for use in an Indication
outside of the Territory.

(mm) “ Purchase Order ” shall be as defined in Section 6.1.

(nn) “ Purpose ” shall be as defined in Section 12.2.

(oo) “ Regulatory Approval ” shall mean, with respect to a particular country in the Territory and an Indication, the approval by all Regulatory Authorities of the Marketing Approval Application and the receipt by Spepharm of the other approvals, licenses, registrations and authorizations of all Regulatory Authorities necessary for the marketing, distribution and sale of a Product in such Territory for use in such Indication and necessary for patients to obtain reimbursement of such Product from national health insurance.

(pp) “ Regulatory Authority ” shall mean each and every Governmental Body from which approvals are required for the marketing, distribution or sale of a Product in a country in the Territory.

(qq) “ Royalty Amount ” shall be as defined in Section 7.1.

(rr) “ Specifications ” shall mean the specifications for a Product approved by the Regulatory Authority for use in the relevant Indication.

(ss) “ Spepharm Releasees ” shall be as defined in Section 10.2.

(tt) “ Term ” shall mean the time period from the Effective Date until the expiration or earlier termination of this Agreement.

(uu) “ Territory ” shall mean the European Union (including countries that accede to the European Union after the date of this Agreement if Valera has not already granted distribution rights for a Product in such country at the time of the accession), Norway and
Switzerland.

(vv) “ Third Party ” means any Person other than a Party or an Affiliate of a Party.

(ww) “ Trademarks ” shall mean, subject to Article 4, all trademarks and trade names and trade dresses (whether registered or not) owned by Valera or its Affiliates and approved by Valera for use in the marketing, distribution and sale of a Product in a country in the Territory for use in a particular Indication.

(xx) “ Transfer Price ” shall be as defined in Section 7.2.

(yy) “ Valera Releasees ” shall be as defined in Section 10.1.

(zz) “ Warranty Period ” shall be as defined in Section 8.4.

1.2 Interpretation. The division of this Agreement into Articles and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement. In this Agreement, words importing the singular number only shall include the plural and vice versa and words importing gender shall include all genders.

Article 2 — Product Development and Regulatory Approval

2.1 Regulatory Approval. Valera shall assign to Spepharm all Marketing Approval Applications and any Regulatory Approval held by Valera with respect to such Products in the Territory. Valera shall submit all necessary paperwork to all Regulatory Authorities to request assignment to Spepharm of all Marketing Approval Applications Regulatory Approval held by Valera with respect to such Products in the Territory. In accordance with the terms and subject to the conditions herein specified, Spepharm shall, at its own expense, apply for each Regulatory Approval for each Product in each country of the Territory for use in each Indication. Spepharm hereby agrees to use commercially reasonable efforts in applying for each such Regulatory Approval, which shall be held in the name of Spepharm or an Affiliate of Spepharm. Valera’s only obligations in regards to the Regulatory Approval effort shall be for Valera to: (a) provide to Spepharm the information and data required by Section 2.2; (b) make personnel available for telephone calls with Spepharm and Regulatory Authorities as Valera determines in its sole discretion; and (c) supplying, at Spepharm’s expense based on Valera’s cost of production, a reasonable quantity of the Product for use in clinical trials as set forth in this Agreement, including any Product necessary for any required stability testing. If Spepharm desires or requires more assistance or resources from Valera in relation to the Regulatory Approval effort, it may request such resources and Valera will determine in its sole discretion whether it will provide such resources and the cost to Spepharm of providing such resources. Spepharm shall not use any Development Data in Ireland unless and until Valera has obtained from Shire US Inc. a license to the Development Data for the development, manufacture, use, supply and sale of the Licensed Product in Ireland (each capitalised term as defined in the Termination Agreement, License Back and Option dated 21 December 2001 between Hydro Med Sciences, Inc. (n/k/a Valera Pharmaceuticals, Inc.) and Shire US Inc.).

2.2 Furnishing Data. Valera shall supply Spepharm with all data and information in its possession or control as is necessary for the purpose of obtaining and maintaining Regulatory Approval for each Product in each country of the Territory for use in each Indication, including clinical and non-clinical study data, results and reports (including toxicology reports) and/or CMC information including, where required, a reasonable number of samples for actual testing by Regulatory Authorities. Without limiting the generality of the foregoing and to the extent legally permitted, Valera shall provide Spepharm with access to and the right to cross-reference existing regulatory filings for each Product submitted by it and/or its Affiliates or designated nominees in any jurisdiction outside of the Territory. At the request of Spepharm and to the extent legally permitted, Valera shall notify the Regulatory Authority in each country of the Territory of Spepharm’s right to reference any such regulatory filings in any application filed by Spepharm in accordance with the terms of this Agreement.

2.3 Development and Regulatory Approval Plans. Within sixty (60) Business Days after the Effective Date, Spepharm shall prepare a plan outlining all pre-clinical, clinical and regulatory activities that are necessary for receiving Regulatory Approval for the use of the Product in the prostate cancer Indication in each country of the Territory and estimated time schedules for the completion of all such activities (the “Plan”). Generally, the Plan shall allocate responsibility for pre-clinical and clinical activities and regulatory activities in each country of the Territory (including development and approval of Territory-specific labeling for the Product) to
Spepharm and shall not allocate any responsibility to Valera other than provision of the data and information required by Article 2 and the supply of the Product. The Plan shall be subject to the review and approval of Valera, which will not be unreasonably withheld or delayed. As new Indications become available during the Term, Spepharm shall develop a Plan for receiving Regulatory Approval from each Regulatory Authority in the Territory for such Product for use in such Indication no later than sixty (60) Business Days after Valera notifies Spepharm of the approval of the Product for marketing, sale and use in the United States in such Indication. Each such Plan shall be subject to the review and approval of Valera, which approval shall not be unreasonably withheld or delayed.

2.4 Clinical Trial Data. All clinical and/or marketing data developed by the Parties during the Term shall remain the property of the Party developing such data, and any data to which both Parties have contributed to or on which both Parties have worked shall remain the property of both jointly and severally worldwide; provided that Valera shall have a perpetual, irrevocable, royalty-free, fully paid-up license to copy, disclose and use in any manner any and all clinical and/or marketing data developed in the course of such trials and not otherwise owned by Valera. The Parties agree that they will promptly share with one another all information and reports regarding the results of any trials.

2.5 Phase IV Clinical Studies. Spepharm shall have the exclusive right (but not the obligation) to conduct Phase IV clinical trials relating to the use of the Product in each Indication in each country of the Territory, but only with the prior written consent of Valera, which consent shall not be unreasonably withheld or delayed.

2.6 Maintaining Regulatory Approval. Spepharm undertakes to use commercially reasonable efforts to maintain each Regulatory Approval for each Product for use in each Indication in each country of the Territory. All reasonable direct out-of-pocket expenses incurred by Spepharm and/or Valera in maintaining the registrations in the Territory shall be borne or reimbursed by Spepharm.

2.7 Copies of Correspondence. Copies of all pertinent correspondence related to the promotion, sale and use of each Product for use in each Indication to and from all Regulatory Authorities and all submissions, or pertinent excerpts thereof, to the Regulatory Authorities connected to each Product for use in each Indication will be furnished by the corresponding Party to the other Party in a timely manner.

2.8 Unit Prices. Spepharm shall, at its own expense, make all submissions and filings to each Government Body and all other Third Parties necessary or desirable to establish unit prices for each Product for use in each Indication in each country of the Territory.

Article 3 — Exclusive Distribution; Promotion and Sales

3.1 Appointment of Distributor. Subject to the terms and conditions of this Agreement, Valera hereby appoints Spepharm during the Term, and Spepharm hereby accepts its appointment, as the exclusive distributor of the Products in each country of the Territory for use in each Indication.

3.2 Exclusive Supply. During the Term, Valera shall not supply any of the Products for distribution or sale in any country of the Territory to any Person other than Spepharm, it being understood between the Parties that Valera shall not directly or indirectly sell, or otherwise make available, any of the Products in any country of the Territory other than through Spepharm in accordance with the terms of this Agreement. Valera shall refer to Spepharm all orders or inquiries received by it from sources in any country of the Territory in connection with any of the Products for use in any Indication.

3.3 Reservation of Rights. In no event shall this Agreement be construed to prevent Valera from directly or indirectly: (a) manufacturing, using, marketing, promoting, distributing and selling any Product outside the Territory for use in any indication; or (b) entering into and performing agreements with third parties regarding the foregoing.

3.4 Sales within each Country of the Territory. Spepharm shall not, and Spepharm shall cause its Affiliates and sublicensees not to, directly or indirectly, without the prior written consent of Valera, sell the Product outside the Territory, or knowingly sell any Product to any Person within any country of the Territory for resale or use outside of the Territory.

3.5 Competing Product. For a period of five (5) years from the date of this Agreement, Spepharm shall not, and shall cause its Affiliates and sublicensees not to, directly or indirectly, jointly or in conjunction with any other Person, whether as principal, agent, shareholder, employee, independent contractor, or in any other manner whatsoever, develop, market, distribute or sell in any country of the Territory any products that contain the same active ingredient as that which is contained in any Product, any products similar to or competitive with any Product, or any products that are used in any Indication (each, a “Competing Product”) without Valera’s prior
written consent.

3.6 Subcontracting. The Parties acknowledge and agree that, subject to prior written notification to and acceptance from the appropriate Regulatory Authority, each Party shall have the right, at its sole expense, to subcontract with Third Parties or Affiliates for the performance of its obligations hereunder, upon prior written approval of the other Party where the subcontractor is a Third Party (which approval shall not be unreasonably withheld or delayed); provided, however, that the subcontracting Party shall remain responsible to the other Party for (a) assuring that each subcontractor complies with all applicable provisions of this Agreement and all
applicable Laws and (b) fulfilling all of its obligations hereunder; and provided further that Spepharm shall have no right to approve or disapprove of any contract manufacturer or contract packager engaged by Valera. In the event that any subcontracting by Valera would have a material impact on Spepharm’s responsibilities to the appropriate Regulatory Authority and to the extent reasonably possible, Valera will inform Spepharm at least six (6) months prior to arranging for any such subcontracting.

3.7 Product Promotion. Spepharm shall employ reasonable efforts to market, distribute and sell each Product in each country of the Territory for use in its relevant Indication and shall bear all costs and expenses incurred in connection with such efforts. The Parties agree to meet at either Party’s reasonable request, but at least once every six months during the Term, in order to review and discuss marketing, distribution and sales issues.

3.8 Promotional Materials. Valera shall provide Spepharm, at no additional cost, with samples of all Promotional Materials owned by Valera to market the Product for use in each Indication outside of the Territory; provided that Spepharm reimburses Valera for all additional advertising agency costs, if any, associated with supplying any artwork and graphics. Valera hereby grants to Spepharm the right to use such Promotional Materials to translate such Promotional Materials and, subject to Article 4, to modify any artwork and graphics for its purpose.

3.9 Marketing Plan. Commencing in the year in which Spepharm submits a Marketing Approval Application to a Regulatory Authority within a particular country for a particular Indication, Spepharm shall prepare, develop and submit to Valera an annual marketing plan in relation to use of such Product for such Indication in such country (each, a “Marketing Plan”) for Valera’s review by no later than the 15th of February of each year during the Term for the then-current Calendar Year. The Marketing Plan will outline plans for the promotion and sale of such Product in such country for such Indication, and will also include recommendations for Product pricing, reimbursement status and activities, positioning, and a description of the promotional programs, if any, planned for the relevant Calendar Year. Valera, acting in good faith, shall have thirty (30) Business Days from the date of receipt to review each Marketing Plan and suggest commercially reasonable changes. Spepharm shall make commercially reasonable efforts to include any changes in the Marketing Plan suggested by Valera and shall advise, in writing, within fifteen (15) Business Days which changes it has incorporated together with an explanation as to any changes that were suggested by Valera but not incorporated. In the event that Valera does not respond to Spepharm within thirty (30) Business Days of the receipt of a Marketing Plan, such Marketing Plan will be deemed to be acceptable to Valera. Notwithstanding anything else contained herein to the contrary, at the request of either Party, the Parties shall meet semi-annually to review proposed marketing plans for the Products.

3.10 Sublicensing. Spepharm may sublicense the distribution rights granted pursuant to Section 3.1; provided that (a) Spepharm enters into a written agreement with the sublicensee that binds the sublicensee to non-economic terms and conditions substantially similar to the non-economic terms and conditions of this Agreement applicable to Spepharm; and (b) prior to entering into such sublicense agreement, Spepharm provides Valera with a full copy of the proposed agreement; and provided, further, that sublicensing to any entity other than an Affiliate of Spepharm shall require prior written consent of Valera, which consent shall not be unreasonably withheld. Valera’s consent is deemed reasonably withheld if the potential sublicensee is a direct competitor of Valera. Sublicensing shall not relieve Spepharm of any of its obligations under this Agreement. Spepharm shall be liable for any sublicensee’s failure to perform any term or condition of this Agreement as if Spepharm itself breached the applicable term or condition of this Agreement.

Article 4 — Branding; Trademarks

4.1 License Grant; Branding. Subject to the terms and conditions of this Agreement, Valera hereby grants Spepharm an exclusive license to use the Trademarks in connection with the marketing, distribution, and sale of the Products in each country of the Territory for use in the applicable Indication. The Products shall bear a product name owned by Valera, which product name shall, if possible, be the same as the product name used in the United States (but may vary by Indication), as well as certain other trademarks of Valera and trademarks of Spepharm (other than a product name of Spepharm) and use the trade dress identified by Valera from time to time and approved by Spepharm; provided, however, that all packaging shall, to the extent legally feasible, ensure that the distinctiveness of the trademarks of each party is maintained and include a tag line that indicates the ownership of each Party’s trademarks.

4.2 Obligations and Conditions. No Promotional Materials bearing the Trademarks may be used without Valera’s prior written approval, which consent shall not be unreasonably withheld or delayed but shall be conditioned upon maintaining the distinctiveness of the trademarks of each Party and including a tag line that indicates Valera’s ownership of the Trademarks. It is agreed by the Parties that in the event that Valera does not respond to Spepharm’s submission of the new Promotional Materials or labeling within ten (10) Business Days, consent shall be deemed to be granted.

4.3 Spepharm’s Trademarks. Spepharm hereby, for itself and on behalf of its Affiliates, grants Valera the right to affix Spepharm’s and its Affiliates’ trademarks, trade names, logos and trade dress on labeling of the Products.

4.4 Changes. Each Party may discontinue, alter or add new trademarks to be used in connection with the labeling and marketing of the Products in each country of the Territory for use in an Indication; provided that: (a) the foregoing shall not be deemed to allow Spepharm to use or place a product name owned by Spepharm or licensed by Spepharm from a Third Party on any Product; and (b) each Party may use up any packaging, labeling or Promotional Materials that it has at the time of the discontinuance, alteration or addition, either in stock or in process.

4.5 No Other Rights; Allocation of Goodwill. Except for the licenses granted by each of Valera and Spepharm to the other under this Agreement, neither Party shall acquire any right, title, or interest in any trademark, trade name, logo or trade dress of the other
Party by reason of this Agreement. Each of Spepharm and Valera shall be responsible for registering, as necessary, its own trademarks, trade names, logos and trade dress. Spepharm acknowledges that all use of any of Valera’s trade names, trademarks, trade dress and logos and all of the goodwill associated therewith shall inure solely to Valera’s benefit. Likewise, Valera acknowledges that all use of any of Spepharm’s trademarks, trade dress, trade names, and logos, and all of the goodwill associated therewith shall inure solely to Spepharm’s benefit.

4.6 Confusingly Similar Marks. Spepharm shall not authorize or undertake any use of any mark that is confusingly similar to the Trademarks in each country of the Territory.

4.7 Effect of Termination. Upon termination of this Agreement both parties shall immediately cease all use of the other party’s trademarks, trade names, logos and trade dress, except as set forth in Article 4.

Article 5 – Manufacture and Supply

5.1 Manufacturing. Valera shall, directly or through an Affiliate or Third Party designee (including contract manufacturers and contract packagers), have the sole right and responsibility for manufacturing the Products in such quantities as, in Valera’s opinion, are required to fill all orders and for maintaining such inventory levels of raw materials and packaging components as are required to meet Spepharm’s then-current forecast for the Products (as delivered pursuant to Section 6.3.

5.2 Labeling. Valera shall supply the Products to Spepharm in unlabeled packaging in bulk. Spepharm shall be responsible for the labeling and packaging necessary to comply with all Regulatory Approvals and bear all costs related to the same. From time to time, and in any event promptly following Valera’s request, Spepharm shall notify Valera of all labeling and packaging activities undertaken by or on behalf of Spepharm to comply with all Regulatory Approvals in the Territory.

5.3 Failure to Supply. In the event that Valera or its Affiliates are unable to supply a Product in specified quality or in quantities sufficient to meet forecast demand for a successive period of ninety (90) Business Days, then Valera shall indemnify Spepharm for all
damages (including lost profits) resulting from such failure based on the difference between Spepharm’s Forecast Net Sales and its actual Net Sales for a period not to exceed eighteen months from the date of Valera’s initial failure to supply.

5.4 Documentation and Certificate of Analysis. Valera shall provide Spepharm with required supporting documentation for the manufacture and packaging of Product in a form suitable for Spepharm’s submission to the Regulatory Authorities. A certificate of analysis and full set of batch manufacturing records shall be delivered with each batch of Product delivered to Spepharm.

5.5 Improvements; New Formulation. Valera shall furnish Spepharm with all information pertinent to the marketing, sale and promotion of a Product relating to any Improvements, which Valera may make from time to time to the Product, or to any new formulation of the Product. To the extent reasonably possible, Valera shall provide Spepharm with six (6) months prior written notice of any anticipated Improvements or new formulations.

5.