SUPPLY AGREEMENT

Exhibit 10.34

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED

SUPPLY AGREEMENT

          This Supply Agreement (the “Agreement” ) is made and entered into effective as of December 19, 2005 (the “Effective Date” ) by and between GPC Biotech AG, a German corporation, having its place of business at Fraunhoferstrasse 20, 82152 Martinsried/Munich, Germany (“GPC Biotech” ); and Pharmion GmbH, a Swiss limited liability company and wholly-owned subsidiary of Pharmion Corporation, a Delaware corporation, having a place of business at Aeschenvorstadt 71, 4051 Basel, Switzerland ( “Licensee” ). GPC Biotech and Licensee are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

           WHEREAS , the Parties have entered into a Co-Development and License Agreement of even date herewith (the “ License Agreement ”), pursuant to which GPC Biotech grants a license to Licensee, and Licensee obtains a license, to Develop and Commercialize the Licensed Product (each as defined therein); and

           WHEREAS , in accordance with the terms of the License Agreement, the Parties are required to enter into an agreement providing for the supply by GPC Biotech to Licensee of all of Licensee’s requirements of the Licensed Product; and

           WHEREAS , GPC Biotech desires to supply the Licensed Product to Licensee, and Licensee desires to purchase the Licensed Product, all on the terms and conditions set forth below.

           NOW, THEREFORE , in consideration of the foregoing premises, the mutual promises and covenants of the Parties contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

ARTICLE I

          Unless otherwise specifically provided herein, the following terms shall have the following meanings:

           1.1 “Affiliate” shall mean, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).

           1.2 “Agreement” shall have the meaning set forth in the preamble to this Agreement.

           1.3 “API” shall mean the Licensed Compound as defined in the License Agreement.

           1.4 “API Facility” shall mean the Manufacturing facility of the API Subcontractor.

           1.5 “API Subcontractor” shall mean, as of the Effective Date, Johnson Matthey Inc. or any other Person appointed by GPC Biotech thereafter and approved by Licensee in writing to supply API, which approval shall not be unreasonably withheld or delayed.

           1.6 “Applicable Law” shall mean applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time.

           1.7 “Arbitration Rules” shall have the meaning set forth in Section 9.11.2.

           1.8 “Breaching Party” shall have the meaning set forth in Section 8.2.

           1.9 “Business Day” shall mean a day other than a Saturday or Sunday on which banking institutions in Munich, Germany are open for business.

           1.10 “Calendar Quarter” shall mean each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1.

           1.11 “Calendar Year” shall mean each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31.

           1.12 “ cGMP ” shall mean (a) the current good manufacturing practices for the methods used in, and the facilities and controls used for, the Manufacture of the Licensed Product promulgated by any Regulatory Authority including, without limitation, US cGMP, the EU Good Manufacturing Guidelines, the International Conference on Harmonization Guidelines and any other applicable laws, guidelines and/or regulations, together with the latest FDA and other applicable guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time.

           1.13 “Claims” shall have the meaning set forth in Section 7.1.

           1.14 “CMC Sections” shall mean the Chemistry, Manufacturing and Controls sections of any Regulatory Documentation, including all information included therein.

           1.15 “Complaining Party” shall have the meaning set forth in Section 8.2.

           1.16 “Dispute” shall have the meaning set forth in Section 9.11.1.

           1.17 “Distributor” shall have the meaning set forth in the License Agreement.

           1.18 “Drug Master File” shall have the meaning set forth in the License Agreement.

           1.19 “Effective Date” shall mean the effective date of this Agreement as set forth in the preamble to this Agreement.

           1.20 “Exploitation” shall have the meaning set forth in the License Agreement.

           1.21 “Facilities” shall mean (a) the API Facility, (b) the Finishing Facility, and (c) any Manufacturing facility of GPC Biotech or its Affiliates.

           1.22 “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto.

           1.23 “FFDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.

           1.24 “Finishing Facility ” shall mean the Manufacturing facility of the Finishing Subcontractor or the Manufacturing facility of GPC Biotech or its Affiliate, as determined by GPC Biotech.

           1.25 “Finishing Subcontractor” shall mean, as of the Effective Date, [...***...] , or any other Person appointed by GPC Biotech thereafter to supply Licensed Product in bulk capsule form, and approved by Licensee in writing, which approval shall not be unreasonably withheld or delayed.

           1.26 “ Forecast(s) ” shall have the meaning set forth in Section 2.2.1.

           1.27 “Full Product Batch” shall mean a specific quantity of Licensed Product equal to approximately 480,000 units comprised of approximately [...***...] units of [...***...] capsules and approximately [...***...] units of [...***...] capsules.

           1.28 “GPC Biotech” shall have the meaning set forth in the preamble to this Agreement.

           1.29 “ Indemnification Claim Notice ” shall have the meaning set forth in Section 7.3.

           1.30 “ Indemnified Party ” shall have the meaning set forth in Section 7.3.

           1.31 “Initial Forecast” shall have the meaning set forth in Section 2.2.1.

           1.32 “Joint Manufacturing Committee” or “JMC” shall have the meaning set forth in Section 2.1.4.

           1.33 “License Agreement” shall have the meaning set forth in the first recital to this Agreement.

           1.34 “Licensed Product” shall mean the “Licensed Product” as defined in the License Agreement that has been Manufactured by or on behalf of GPC Biotech and delivered to Licensee pursuant to the terms of this Agreement.

           1.35 “Licensee” shall have the meaning set forth in the preamble to this Agreement.

           1.36 “Licensee Territory” shall have the meaning set forth in the License Agreement.

           1.37 “Losses” shall have the meaning set forth in Section 7.1.

           1.38 “Major Market Country” shall have the meaning set forth in the License Agreement.

           1.39 “Manufacturing” shall mean all activities, steps and processes relating to the production, manufacture, processing and holding of the Licensed Product or any intermediate thereof, including stability testing, quality assurance and quality control. The terms “ Manufacture ” and “ Manufactured ” refer to the act of Manufacturing.

           1.40 “Manufacturing Cost” shall have the meaning set forth in the License Agreement.

           1.41 “Manufacturing Process” shall mean any process or step thereof that is necessary or useful for Manufacturing the Licensed Product or any intermediate thereof as evidenced in the batch records or master batch records.

           1.42 “Materials” shall mean all raw materials, excipients, and containers required in connection with the Manufacture of the Licensed Product, excluding API.

           1.43 “Notice Period” shall have the meaning set forth in Section 8.2.

           1.44 “Party” and “Parties” shall have the meaning set forth in the preamble to this Agreement.

           1.45 “ Permits ” shall have the meaning set forth in Section 6.1.1.

           1.46 “Person” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

           1.47 “ Purchase Order ” shall mean a written purchase order submitted by Licensee to GPC Biotech in accordance with Section 2.2.2.

           1.48 “Quality Agreement” shall mean the quality assurance agreement between the Parties to be agreed upon within ninety (90) days of the Effective Date.

           1.49 “Regulatory Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of the Licensed Product in the Licensee Territory.

           1.50 “Regulatory Documentation” shall have the meaning set forth in the License Agreement.

           1.51 “Reserve Inventory” shall have the meaning set forth in Section 2.1.2.

           1.52 “ Specifications ” shall mean the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Licensed Product, at any stage of Manufacture, should conform to be considered acceptable for its intended use as agreed to in writing by the Parties within ninety (90) days of the Effective Date, as such specifications are amended or supplemented from time to time in accordance with the terms hereof. Without limiting the generality of the foregoing, the Specifications shall be consistent with all applicable Regulatory Documentation filed prior to the Effective Date and shall specify that the Licensed Products, when delivered to Licensee, shall have a minimum remaining shelf life of not less than seventy five percent (75%) of the maximum shelf life that is available for the Licensed Products at the time of Manufacture.

           1.53 “Subcontractor” shall mean either the API Subcontractor or the Finishing Subcontractor.

           1.54 “Sublicensee” shall have the meaning set forth in the License Agreement.

           1.55 “Supply Failure” shall have the meaning set forth in Section 8.5.

           1.56 “Supply Price,” with respect to any Licensed Product delivered hereunder, shall mean one hundred and ten percent (110%) of the Manufacturing Costs for such Licensed Product.

           1.57 “ Term ” shall have the meaning set forth in Section 8.1.

           1.58 “Third Party” shall mean any Person other than GPC Biotech, Licensee and their respective Affiliates and Sublicensees.

           1.59 “US cGMP” shall mean current good manufacturing practices for the methods used in, and the facilities and controls used for, the Manufacture of the Licensed Products, all as set forth from time to time by the FDA pursuant to the FFDCA and the rules and regulations promulgated thereunder (including specifically Title 21, parts 210 and 211 of the Code of Federal Regulations of the United States).

ARTICLE II

           2.1 Purchase and Supply Obligations. Subject to the provisions of this Agreement, during the Term Licensee shall, and Licensee shall cause its Sublicensees to, purchase one hundred percent (100%) of their requirements of Licensed Product in bulk capsule form according to the Specifications for sale in the Licensee Territory from GPC Biotech, and GPC Biotech shall Manufacture and supply such quantities of Licensed Product to Licensee. GPC Biotech shall not supply Licensed Products to any Third Party within the Licensee Territory. In the event that GPC Biotech, at any time during the Term, has reason to believe that it or any Subcontractor will be unable to perform the services hereunder or that there will be a material delay in performance thereof, GPC Biotech shall (without limiting any other obligations GPC Biotech may have or rights or remedies Licensee may have ) promptly notify Licensee thereof.

                2.1.1. Subcontracting. Licensee acknowledges and agrees that GPC Biotech may subcontract or delegate any or all of its obligations hereunder to any Subcontractor; provided that any change in Subcontractors requires Licensee’s prior written consent and such subcontracting or delegation shall in no way relieve GPC Biotech of its obligations hereunder except to the extent that such obligations are performed by a Subcontractor. GPC Biotech shall ensure that any Subcontractor engaged by GPC Biotech to Manufacture Licensed Product Manufactures the Licensed Product pursuant to the terms of this Agreement.

                2.1.2. API and Materials; Reserve Inventory . GPC Biotech or its Subcontractors shall obtain and provide all API, Materials and equipment required to Manufacture the Licensed Products hereunder. During the Term of this Agreement, GPC Biotech shall maintain, at its own expense, a reserve inventory of API and capsule shells to be used in the future Manufacturing of Licensed Products (“Reserve Inventory”) in an amount equal to twice Licensee’s Forecast for the then-current Calendar Quarter. When using Reserve Inventory in order to Manufacture Licensed Products in accordance with this Agreement, GPC Biotech and its Subcontractors shall manage such inventory with its own inventories of API and Materials on a “first expiry, first out” basis to maximize shelf life and minimize spoilage. GPC Biotech shall properly store all inventories of API and Materials (including such Reserve Inventory) prior to use in accordance with cGMP and the Specifications.

                2.1.3. Facilities . GPC Biotech shall Manufacture all Licensed Product hereunder only at the Facilities. GPC Biotech shall maintain, or shall cause its Subcontractors to maintain, at their own expense, the Facilities and all equipment required for the Manufacture of the Licensed Product in a state of repair and operating efficiency consistent with the requirements of cGMP and all other Applicable Law.

                2.1.4. Joint Manufacturing Committee. The JEC (as defined in the License Agreement) will establish a Joint Manufacturing Committee comprising an equal number of representatives of both Parties (the “JMC”). The JMC shall have the overall responsibility for overseeing the Parties’ activities with respect to the Manufacture of Licensed Product hereunder and, in particular, the JMC shall (a) discuss any proposed changes to the Manufacturing Process or Specifications; (b) oversee and coordinate regulatory activities relating to Manufacturing; (c) oversee and establish work plans for analytical methods transfer; (d) coordinate product supply activities; and (e) engage in any other activities or assume any other responsibilities delegated to it by the JEC. The JEC will establish the meeting schedule and decision-making rules that the JMC will follow in carrying out its responsibilities.

2.2 Forecasts and Purchase Orders.

                2.2.1. Not later than ninety (90) days following the Effective Date, Licensee shall provide GPC Biotech with a good faith, written forecast of its anticipated requirements of the Licensed Product and proposed delivery dates thereof for the period beginning on the Effective Date and ending six (6) full Calendar Quarters thereafter (“ Initial Forecast ”). Not later than thirty (30) days prior to the beginning of the first full Calendar Quarter after the Initial Forecast and each subsequent full Calendar Quarter of the Term, Licensee shall submit to GPC Biotech a good faith, written forecast of its anticipated requirements of the Licensed Product and proposed delivery dates thereof for such Calendar Quarter and the five (5) Calendar Quarters thereafter (such forecasts, together with the Initial Forecast, the “ Forecasts ”) (for example, not later than thirty (30) days prior to the Calendar Quarter that begins April 1, 2007, Licensee shall submit a Forecast covering the period from April 1, 2007 through September 30, 2008). The quantities of Licensed Product and delivery dates applicable to the first two (2) Calendar Quarters in each Forecast shall constitute a binding obligation of Licensee to purchase and of GPC Biotech to supply such quantities and shall not be subject to change without the prior written approval of both GPC Biotech and Licensee.

                2.2.2. Licensee shall order Licensed Product by the issuance of Purchase Orders to GPC Biotech at least one hundred twenty (120) days prior to the delivery date specified in each respective Purchase Order. Each Purchase Order shall designate the desired quantities of Licensed Product and the delivery date(s) thereof, and each Purchase Order must be consistent with the binding portion of the most recently delivered Forecast and shall constitute a binding commitment by Licensee to order from GPC Biotech and by GPC Biotech to deliver to Licensee when placed. All Purchase Orders shall be for Full Product Batch quantities of Licensed Product or integral multiples thereof.

                2.2.3. GPC Biotech shall confirm acceptance of each Purchase Order submitted in accordance with Section 2.2.2 within thirty (30) days after receipt thereof and shall use commercially reasonable efforts to deliver

Licensed Product against each Purchase Order in accordance with the delivery date set forth therein.

                2.2.4. Each Purchase Order shall be subject to all of the terms and conditions of this Agreement. To the extent any terms or provisions of a Purchase Order or the written acceptance thereof by GPC Biotech conflict with, or are in addition to, the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control.

           2.3 Delivery Terms; Risk of Loss. GPC Biotech shall deliver all Licensed Product Manufactured hereunder EXW (as defined in Incoterms 2000) the Finishing Facility. Title to all Licensed Product shall pass to Licensee at the time of delivery.

           2.4 Regulatory Approvals. GPC Biotech shall, and shall cause its Subcontractors to, permit any applicable Regulatory Authority to inspect the Facilities and otherwise cooperate fully with such agencies and GPC Biotech shall, and shall cause its Subcontractors to, provide Licensee with such information and assistance as Licensee may reasonably request in order for Licensee to comply with the requirements of such Regulatory Authorities in regard to the Licensed Product. The Parties further agree that GPC Biotech shall, and shall cause its Subcontractors to, use commercially reasonable efforts, at Licensee’s expense, to cooperate in any registration process in the Licensee Territory undertaken by Licensee in accordance with the License Agreement. On or prior to the date agreed to by the Parties (in consultation with the JMC) in connection with the Development of the Licensed Product, GPC Biotech shall, and shall cause its Subcontractors to, at its expense, compile and file a Drug Master File with all Regulatory Authorities in the Major Market Countries in the Licensee Territory that accept such filings. If any Regulatory Authorities in the Licensee Territory do not allow for referencing Drug Master Files for purposes of obtaining Regulatory Approval for the Licensed Product, GPC Biotech shall, and shall cause its Subcontractors to, provide Licensee with all information required to complete the CMC Sections of any Regulatory Documentation required to be submitted in the Major Market Countries in the Licensee Territory as soon as reasonably practicable.

           2.5 Change Control. GPC Biotech shall Manufacture Licensed Product according to cGMP and the applicable Specifications. GPC Biotech shall notify Licensee of any and all changes it proposes in its Manufacturing (including API and Materials), Subcontractors, Facilities, Manufacturing Process or Specifications relating to Licensed Product. GPC Biotech or Licensee may, at any time, request a change to the Manufacturing Process or the Specifications related to the Licensed Product. GPC Biotech and its Subcontractors agree to implement any change to the Manufacturing Process or Specifications that is required by a Regulatory Authority or by Applicable Law in the Licensee Territory. In the event of any other request to modify the Manufacturing Process or Specifications, both Licensee and GPC Biotech shall promptly meet to evaluate such proposed changes including the effect of such changes on the regulatory filings related to the Licensed Product and the costs associated with Manufacturing. No such change shall be made without the approval of both Parties; provided that such approval shall not be unreasonably withheld. To the extent that any change is required by Regulatory Authorities in both the GPC Biotech Territory and the Licensee Territory, the costs associated with implementing such change will be considered Collaboration Costs under

the License Agreement. The costs associated with implementing all other changes will be the responsibility of (a) GPC Biotech, if GPC Biotech or its Subcontractors requested the change or the change was required by Regulatory Authorities anywhere in the GPC Biotech Territory, or (b) Licensee, if Licensee requested the change or the change was required by Regulatory Authorities anywhere in the Licensee Territory.

           2.6 Lot Numbers. GPC Biotech shall imprint the lot numbers and expiration dates on Licensed Product containers, as required by cGMP, for each Licensed Product delivered. Such lot numbers and expiration dates shall be assigned to each lot by GPC Biotech based on GPC Biotech’s or its Subcontractor’s standard operating procedures.

           2.7 Analytical Methods Transfer. Licensee shall be responsible for primary and secondary packaging and release testing for Licensed Products to be sold by Licensee in the Licensee Territory. In accordance with a work plan and budget to be agreed upon by Licensee and GPC Biotech, GPC Biotech shall provide Licensee with (a) validated analytical methods and reference standards; (b) details of the packaging materials that GPC Biotech has used for its stability studies; and (c) technical support required to transfer the methods to a Third Party laboratory selected by Licensee to perform release testing of Licensed Product provided to Licensee hereunder. The transfer of analytical methods and other related technology hereunder shall be under the supervision and direction of the JMC. Licensee shall pay GPC Biotech’s actual out-of-pocket expenses in connection with conducting the activities described in this Section 2.7.

           2.8 Licensed Product Failure and Rejection; Latent Defects. With each delivery of Licensed Product hereunder, GPC Biotech shall provide a Certificate of Analysis and a Certificate of Compliance, in a form agreed to by the Parties, along with all other documentation required pursuant to the Quality Agreement. Within thirty (30) days following delivery to Licensee of such Licensed Product and all such documentation, Licensee shall have the right to give GPC Biotech notice of rejection of any batch of Licensed Product that, in whole or part, fails to meet the applicable Specifications at the time of delivery. Failure by Licensee to give notice of rejection within the period set forth above shall be deemed acceptance by it of the Licensed Product to which the notice of rejection would have otherwise applied. GPC Biotech retains the right of appeal to an independent laboratory as provided in Section 2.16 of this Agreement. Notwithstanding the foregoing, the requirement for Licensee to provide notice of rejection within the period set forth above shall not apply to any defect not readily discoverable by Licensee within such thirty (30) day period. In the event of any Licensed Product with defects not readily discoverable by Licensee within such thirty (30) day period, notwithstanding anything to the contrary contained herein, Licensee may reject such Licensed Product by delivering notice of rejection to GPC Biotech no later than the earlier of: (a) thirty (30) days after the date of discovery of such defect or (b) expiration of the shelf life of the Licensed Product. If Licensee fails to notify GPC Biotech of such defect within such time period, Licensee shall be deemed to have accepted such Licensed Product. Licensee shall promptly supply GPC Biotech with any evidence it has that relates to whether any Licensed Product delivered to Licensee by GPC Biotech fails to meet the applicable Specifications.

           2.9 Inspection. Licensee shall have the right, no more than once during any Calendar Year during the Term, except for any additional “for cause” inspections where Licensee has been informed of quality issues at any of the Facilities, to enter the Facilities upon

reasonable advance notice and during normal business hours for the purpose of inspecting the Facilities, procedures and any relevant records relating to the Manufacture of Licensed Product (including all batch sheets and records for all Manufacturing steps); provided, however, that, with respect to any audit of a Subcontractor’s facility, Licensee agrees to enter into a customary confidentiality agreement reasonably acceptable to such Subcontractor prior to such audit and upon such Subcontractor’s request; and provided further, that any inspection of the API Facility or Finishing Facility shall be coordinated with any inspection planned by GPC Biotech. No such inspection shall diminish or increase GPC Biotech’s obligations hereunder, except that GPC Biotech shall, and shall cause its Subcontractors to, undertake to use commercially reasonable efforts to correct promptly any deficiencies reasonably identified by Licensee in such inspection. In the event that any Facility used in the Manufacturing of Licensed Product hereunder is inspected by representatives of any Regulatory Authority in connection with the Manufacture of the Licensed Product, GPC Biotech shall notify Licensee immediately by telephone and follow up in writing, upon learning of such inspection, and shall promptly supply Licensee with copies of any reports or responses prepared by the Regulatory Authority, GPC Biotech or the applicable Subcontractor relating to such inspection. Licensee may send representatives to such Facility and Licensee may participate in any portion of such inspection relating to the Licensed Product of which GPC Biotech receives advance notice.

           2.10 Manufacturing Records. GPC Biotech shall, and shall cause its Subcontractors to, maintain adequate and accurate books and records with respect to its and their activities hereunder, including Manufacturing records and lot traceability records, with respect to each Licensed Product lot delivered hereunder. These records shall be retained until Licensee gives GPC Biotech written consent for records to be destroyed, which consent shall not be unreasonably withheld; provided, however , that in no event shall records be destroyed at any time when such records are required to be retained by Applicable Law. Notwithstanding the foregoing, GPC Biotech shall, prior to discarding any documentation related to the Manufacture of Licensed Product, make such documentation available for collection by Licensee at Licensee’s expense.

           2.11 Batch Records. Upon request by Licensee, GPC Biotech shall make available for review copies of the individual and master batch records received from Subcontractors and used for any step in the Manufacture of Licensed Product delivered hereunder. Licensee may use the information in such batch records as provided in the License Agreement, including in regulatory submissions in order to gain or maintain regulatory approvals.

           2.12 Deviations. GPC Biotech agrees that it or its Subcontractor’s quality assurance function shall review the Manufacturing records for all steps and all lots of Licensed Product delivered hereunder. Upon discovery of any deviation from cGMP or from any warranty hereunder, GPC Biotech shall promptly notify Licensee and conduct an appropriate investigation to determine the cause of such deviation and take appropriate action at its expense to avoid recurrence. GPC Biotech shall provide Licensee with the applicable documentation of such deviations and report to Licensee on the results of the subsequent investigation and corrective actions taken to address such deviations.

           2.13 Warning Letters. Each Party shall promptly notify the other Party of, and provide the other Party with copies of, any correspondence and/or other documentation received or prepared by the Party in connection with receipt of any warning letter or other regulatory correspondence from the FDA or any other Regulatory Authority in connection with the Manufacture of the Licensed Product; provided that GPC Biotech may redact from such communications portions thereof which it is required to keep confidential pursuant to binding agreements with Third Parties.

           2.14 Annual Reports. GPC Biotech shall supply, on a Calendar Year basis, Licensed Product data related to applicable complaint test results, all investigations (regarding Manufacturing) and the like, at Licensee’s expense, which Licensee reasonably requires in order to complete any filing under any applicable regulatory regime, including any annual product review report that Licensee is required to file with any applicable Regulatory Authority.

           2.15 Communication With Governmental Agencies. Subject to the rights and obligations set forth in the License Agreement, each Party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Licensed Product, regarding such Licensed Product if, in the opinion of that Party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; provided, however , that, unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such Party shall permit the other Party to accompany and take part in relevant communications with the agency, to receive copies of all such communications from the agency and to review and provide comments on any written communication with any Regulatory Authority or other government agency prior to submitting such communication.

           2.16 Quality Claims.

                     2.16.1. Independent Laboratory . In the event of any disagreement between GPC Biotech and Licensee relating to Licensed Product conformance to the Specifications at the time of delivery thereof by GPC Biotech to Licensee, the Parties shall use good faith efforts to reach an am