DEVELOPMENT AND CLINICAL MANUFACTURING AGREEMENT

Exhibit 10.2

DEVELOPMENT AND CLINICAL MANUFACTURING AGREEMENT

      This Development and Clinical Manufacturing Agreement (the “Agreement”) is made as of April 18th, 2005, (the “Effective Date”) between Advancis Pharmaceutical Corporation existing under the laws of United States of America and having an address at 20425 Seneca Meadows Parkway, Germantown, Maryland 20876 (“Advancis”) and Clonmel Healthcare Limited existing under the laws of Ireland and having an address at Waterford Road, Clonmel Co, Tipperary, Ireland (“Clonmel”), each a “Party” and collectively, the “Parties.”

RECITALS

      A. Clonmel operates a multi-client manufacturing facility located at Waterford Road, Clonmel, Co. Tipperary, Clonmel, Ireland (the “Facility”).

      B. Advancis desires to have Clonmel manufacture certain products for certain clinical trials, site specific stability batches, scale-up, process development and validation batches and Clonmel desires to manufacture such products.

      NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, Clonmel and Advancis, intending to be legally bound, hereby agree as follows:

AGREEMENT

      When used in this Agreement, capitalized terms shall have the meanings as defined below and throughout the Agreement. Unless the context indicates otherwise, the singular shall include the plural and the plural shall include the singular.

       1.1 “Advancis Approved Suppliers” means those suppliers approved by Advancis and as listed in Schedule 4 and as modified from time to time by mutual written agreement of the Parties.

       1.2 “Advancis Intellectual Property Rights” means Intellectual Property Rights made, conceived, developed or reduced to practice during the Term by (a) Advancis or its employees or agents; or (b) by Clonmel or its employees or agents; or (c) jointly by Advancis and Clonmel or their employees or agents; and that relate to Product and/or the manufacture or use thereof and/or Confidential Information of Advancis.

       1.3 “Affiliate” means any person, corporation, company, partnership, joint venture and / or entity which, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with a party.

       1.4 “Applicable Law(s)” means the laws, rules, and regulations, including any statutes, rules, regulations, or other requirements, that may be in effect from time to time and that apply to the development, manufacture, registration, and marketing of Clinical Materials, Site Specific Stability Batches and Validation Batches in the United States and the European Union and its member states, including any such statutes, rules, regulations, or other requirements of the FDA and the EMEA and/or to the manufacture of Clinical Materials, Site Specific Stability Batches and Validation Batches at the Facility.

       1.5 “Approved Master Production Record” has the meaning set forth in Section 2.1(c).

       1.6 “Batch” means a specific quantity of Clinical Materials, Site Specific Stability Batches and Validation Batches that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

       1.7 “Batch Record” means the production record pertaining to a Batch.

       1.8 “cGMP” means the current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211 and related regulations as amended from time to time.

       1.9 “Clinical Materials” means Product for administration to patients in clinical trials.

       1.10 “Clonmel Intellectual Property Rights” means any Intellectual Property Rights made, conceived, developed or reduced to practice by Clonmel or its employees or agents on, before or after the Effective Date; and excluding any Advancis Intellectual Property Rights.

       1.11 “Clonmel Operating Documents” means the standard operating procedures, standard manufacturing procedures, protocols, validation documentation, and supporting documentation, such as environmental monitoring, for operation and maintenance of the Facility and Clonmel equipment used in the process of producing Clinical Materials, Site Specific Stability Batches and Validation Batches, excluding any of the foregoing that are unique to the manufacture of Clinical Materials, Site Specific Stability Batches and Validation Batches, excluding the Process and the Approved Master Production Record.

       1.12 “Competent Authorities” means any national or local agency, authority, department, inspectorate, minister official, parliament or public or statutory person (whether autonomous or not) of any government of any country having jurisdiction over either any of the activities contemplated by this Agreement or over the parties, including the European Commission, The Court of First Instance and the European Court of Justice, the FDA, EMEA or other governmental health authority.

       1.13 “Control” and the correlative meanings “controlled by” and “under common control with” means, for purposes of the definition of Affiliate only, the beneficial ownership, directly or indirectly, of more than 50% of the issued share capital or other comparable equity or ownership interest with respect to a business entity or the legal power to direct or cause direction of the general management and policies of the party in question.

       1.14 “Development and Technology Transfer Plan” means the development and technology transfer plan between the Parties dated as of the date of this Agreement for developing the Process to manufacture Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches attached hereto as Schedule 1 and any amendments thereto that are mutually agreed in writing from time to time by the Parties.

       1.15 “EMEA” means the European Agency for the Evaluation of Medicinal Products or any other successor agency where approval is necessary to market the Product in Europe.

       1.16 “FDA” means the U.S. Food and Drug Administration, and any successor agency thereof.

       1.17 “FCA” has the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560.

       1.18 “Facility” means Clonmel’s production facility at Waterford Road, Clonmel, Co Tipperary.

       1.19 “Facilities Build Out Agreement” shall mean the Facilities Build Out Agreement entered into between the parties on.

       1.20 “Force Majeure” in relation to any Party means any event or circumstance which is beyond the reasonable control of that Party which event or circumstance that Party could not reasonably be expected to have taken into account at the date of this Agreement and which results in or causes the failure of that Party to perform any or all of its obligations under this Agreement including act of God, lighting, fire, storm, flood, earthquake, strike, act of the public enemy, war, terrorist act, blockade, governmental restraint, act of legislature or requirement of governmental authority.

       1.21 “Intellectual Property Rights” means any Patent Right, invention, registered design, design right, copyright, database right, trade mark, service mark, application to register any of the aforementioned rights, trade secrets, confidential information, and all rights in Know-How or equivalent rights recognized in any jurisdiction.

       1.22 “Know-How” means any technical and other information which is not in the public domain, including information comprising or relating to concepts, discoveries, data, formulae, ideas, inventions (whether patentable or not), procedures for experiments and tests and results of research or development, laboratory records, processes including manufacturing processes, specifications and techniques, clinical trial data and information contained in submissions to Competent Authorities.

       1.23 “Manufacturing and Supply Agreement” means the Manufacturing and Supply Agreement to be entered into between the parties.

       1.24 “Latent Defect” has the meaning set forth in Section 3.5.

       1.25 “Master Production Record” means the documentation that contains a detailed description of the Process and any other instructions to be followed by Clonmel in the production of Clinical Materials, Site Specific Stability Batches and Validation Batches.

       1.26 “Material Specifications” means the Materials specifications set forth in Schedule 3 and as modified from time to time by mutual written agreement of the Parties.

       1.27 “Materials” means all raw materials and supplies provided by Advancis and / or an Advancis Approved Supplier to Clonmel to be used in the manufacturing of the Clinical Materials, Site Specific Stability Batches and Validation Batches.

       1.28 “Materials Warranty” means those warranties set forth in Section 3.2.

       1.29 “Patent Rights” means design and utility patent applications and patents (including provisional patent applications), author certificates, inventor certificates, utility certificates, improvement patents and utility models and certificates of addition and all foreign counterparts of them in all countries, including any divisional applications and patents, filings, renewals, continuations, continuations-in-part, patents of addition, extensions (including patent term extensions), reissues, substitutions, confirmations, registrations, revalidation and additions of or to any of them, as well as any supplementary protection certificates and equivalent protection rights in respect of any of them.

       1.30 “Process” means the manufacturing process for Clinical Materials, Site Specific Stability Batches and Validation Batches in accordance with the Approved Master Production Record.

       1.31 “Product” means [***].

       1.32 “Product Specifications” means the finished Product specifications set forth in Schedule 2 and as modified from time to time by mutual written agreement of the Parties.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

       1.33 “Product Warranties” means those warranties set forth in Section 3.1.

       1.34 “Regulatory Approval” means the approval by the FDA to market and sell Product in the United States.

       1.35 “Site Specific Stability Batches” means site specific stability batches of the Product and scale up batches of the Product produced by Clonmel as set out in the Development and Technology Transfer Plan and subsequently put on a formal stability program.

       1.36 “Shipping Documentation” means the documents, including but not limited to certificates of analyses, MSDS and packaging slip summarizing the contents of the shipment as set forth in the Approved Master Production Record.

       1.37 “SOP” means a standard operating procedure.

       1.38 “Term” means the period commencing on the Effective Date and terminating on the date of expiration or termination of this Agreement as set out in Section 9.

       1.39 “Validation Batches” means the validation batches of the Product as set out in the Development and Technology Transfer Plan.

       1.40 “Third Party” means any party other than Clonmel, Advancis or their respective Affiliates.

       2.1 (a) Clonmel and Advancis agree to collaborate and cooperate with each other in developing the Process at the Facility to manufacture Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches, all in accordance with the work outlined in the Development and Technology Transfer Plan and in accordance with the requirements set forth in the Development and Technology Transfer Plan.

      (b) Clonmel and Advancis shall cooperate in the preparation of a Master Production Record. The Master Production Record shall include but not be limited to (i) manufacturing Batch Records including SOPs; (ii) quality control tests; and (iii) Clinical

Materials, Site Specific Stability Batches and Validation Batches packing and shipping instructions. The Master Production Record shall be prepared under the direction of Advancis.

      (c) Upon approval in writing by both Parties of the Master Production Record, the Master Production Record shall become the Approved Master Production Record. The Approved Master Production Record may be modified from time to time by mutual written agreement of the Parties.

      (d) Clonmel shall provide sufficient space within the facility for use as an Analytical Laboratory which will contain all analytical equipment supplied by Advancis. Advancis will supply all analytical equipment listed on Schedule 6 . It is understood that this is all the equipment necessary for both development and commercial operations.

      Clonmel shall provide Advancis and Advancis’ employees and agents access to the Facility only for the purposes of performing activities under the Development and Technology Transfer Plan. Advancis shall have the right to direct and supervise activities of Clonmel employees at the Facility with respect to activities under the Development and Technology Transfer Plan. Advancis shall be provided with an office including telephone and computer connections at the Facility for use by Advancis during the Term.

      (e) Advancis employees working at the Facility shall be and remain employees of Advancis, and shall not become employees or agents of Clonmel at any time, and Advancis shall be solely responsible for the payment of compensation for such Advancis employees (including applicable federal, state and local laws withholding, FICA, pay related social insurance (P.R.S.I.) or similar contributions to the extent applicable, and other payroll taxes, workers’ compensation insurance, health insurance, pension, bonus, and other similar statutory and fringe benefits (the “Employee Benefits”)).

      (f) Advancis hereby agrees to indemnify and hold harmless Clonmel against any claims or demands that may be made by the relevant authorities or any other Third Party in respect of any such Employee Benefits.

      (g) The Process, Product Specifications, Material Specifications, SOPs and any improvements or modifications thereto developed during the Term in relation to the Product and / or Advancis Intellectual Property Rights shall be owned by Advancis and shall be deemed Confidential Information of Advancis and subject to the provisions set forth in Section 6. Advancis is permitted to use (itself or through a third party), the Process and/or the Approved Master Production Record to manufacture Product or to engage a third party as a contract manufacturer of Product.

(h) With respect to work performed under the Development and Technology Transfer Plan by Clonmel, during each shift during which Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches is being manufactured at the Facility, each Clonmel employee assigned to such work shall be dedicated to such work during the entire shift unless otherwise agreed to in writing by Advancis.

(i) With respect to the Materials supplied by Advancis to Clonmel, for use at the Facility pursuant to the Development and Technology Transfer Plan, title and risk of loss of such Materials shall pass to Clonmel on delivery of the Materials at the Facility.

(j) For scale up, process development and Validation Batches, Materials shall be processed through Clonmel’s commercial purchasing and release systems in conjunction with specifications and processes established and/or previously agreed to by Advancis.

(k) [***] shall supply to [***], such quantities of Materials as Clonmel requires for the manufacture and supply of Site Specific Stability Batches and Clinical Materials [***] and, [***] shall obtain from [***] the Materials [***] for manufacture and supply of Validation Batches for Advancis:

a) free from any liens or encumbrances;

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

b) conforming to Material Specifications and, in all material respects, to Applicable Laws;

c) in sufficient quantities and on time to enable Clonmel to meet Advancis’ requirements;

d) labelled in accordance with Clonmel’s requirements communicated to Advancis and or the Advancis Approved Suppliers, in particular as required pursuant to any Regulatory Approval and so as to permit safe storage and transport;

e) with a certificate of analysis in respect of Material, in a form reasonably acceptable to Clonmel (and Clonmel shall be entitled to rely upon such certificate of analysis without the necessity of performing additional testing).

(l) In the event that there are delays in the supply of any information, data or Materials by Advancis and / or the Advancis Approved Suppliers, or delays by any government agency or authority, in each case, other than those caused by Clonmel, which will [***] affect Clonmel’s ability to manufacture Clinical Materials, Site Specific Stability Batches and / or Validation Batches, the Parties shall agree [***] and amend the Development and Technology Transfer Plan[***].

(m) Subject to Section 2.1(l), Clonmel agrees to use [***] to complete the work set forth in the Development and Technology Transfer Plan in accordance with the Development and Technology Transfer Plan, including the schedules set forth therein. [***].

(n) Clinical Materials and Site Specific Stability Batches manufactured pursuant to this Agreement shall be used by Advancis solely for research and development purposes, including but not limited to stability studies and clinical studies, and not for commercial

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

purposes. Advancis shall have the right to use Validation Batches for any and all purposes in accordance with the terms of the Manufacturing and Supply Agreement.

(o) Where Advancis provides any Materials to Clonmel, or where any Materials are provided to Clonmel by an Advancis Approved Supplier, in each case, with respect to Site Specific Stability Batches and/or Clinical Materials, Advancis shall be responsible for ensuring that all such Materials are provided on time and in accordance with the Material Specifications. Clonmel shall be responsible for ensuring that all Materials for Validation Batches are provided on time and in accordance with Material Specifications.

(p) Prior to the receipt by Clonmel of any Materials provided by Advancis or any Advancis Approved Supplier, in each case, with respect to Site Specific Stability Batches and/or Clinical Materials, Advancis shall supply Clonmel with procedures and warnings necessary to help assure the safe handling and use of the Materials.

(q) In addition to the payments under Section 2.7(c) Advancis shall pay Clonmel for (i) the use of the Facility, (ii) the work performed by or on behalf of Clonmel under the Development and Technology Transfer Plan; and (iii) the Batches of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches manufactured under the Development and Technology Transfer Plan, in each case, in the amounts and at the times set forth in the Development and Technology Transfer Plan. Except for the specific amounts set forth in the Development and Technology Transfer Plan, Advancis shall not be required to make any additional payments unless the amount is authorized by Advancis in advance in writing.

       2.2 Manufacture by Clonmel . Clonmel shall manufacture, package, ship, handle, and provide quality assurance for Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches that are manufactured under this Agreement, as set forth in the Approved Master Production Record and in accordance with cGMP and in all material respects in accordance with Applicable Laws, and to deliver to Advancis the quantities of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches set forth in the Development and Technology Transfer Plan, in accordance

with the schedule set forth therein, or any Additional Materials and Batches that Clonmel has agreed to manufacture pursuant to Section 2.7.

       2.3 Packaging and Shipping . Clonmel shall package and label Clinical Materials, Site Specific Stability Batches and Validation Batches for shipment in accordance with the Approved Master Production Record. Clonmel shall deliver Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches FCA (having the meaning and importing the rights and obligations provided in Incoterms 2000) delivered at the Facility to a common carrier for shipment designated by Advancis to Clonmel in writing and risk shall pass accordingly. Advancis shall pay for all shipping costs in connection with each shipment of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches. Each shipment shall be accompanied by the Shipping Documentation. Clonmel shall [***] to deliver each shipment of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches to Advancis on the delivery date for such shipment scheduled in the Development and Technology Transfer Plan. Should Clonmel at any time during the term of this Agreement have reason to believe that it shall be unable to meet a delivery date, Clonmel shall promptly notify Advancis.

      Advancis shall be responsible for ensuring that all storage, shipping, handling and distribution of Product by Advancis and/or any Third Party on behalf of Advancis, including without limitation any agents and sub-contractors of Advancis, is in accordance with, in all material respects, Applicable Laws.

       2.4 The title to any consignment of the Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validity Batches shall pass to Advancis upon delivery to the carrier.

       2.5 Complaints and Clinical Material Recall . Advancis shall notify Clonmel promptly in writing of any complaints from Third Parties reported to Advancis involving any adverse reactions resulting from the use of the Clinical Materials.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

       2.6 Records . Clonmel shall maintain accurate records for the production of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches as required by Applicable Laws, including cGMP regulations and shall retain such records for the longer of [***] or the period required by relevant Applicable Law. Clonmel shall retain ownership of Clonmel Operating Documents, and shall make copies thereof available to Advancis upon Advancis’ request. Clonmel Operating Documents shall remain Clonmel Confidential Information. Advancis shall have the right to use, read, audit and reference any of the foregoing in connection with a filing for Regulatory Approval of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches; in connection with the review of manufacturing activities related to preventive maintenance, calibrations, equipment validations, testing, housekeeping, or personnel training, or as otherwise authorized by the Agreement under Section 6. Advancis shall own the Approved Master Production Record and all Batch Records. Clonmel shall be entitled to retain possession of the originals thereof in the files of Clonmel, as Confidential Information of Advancis.

       2.7 Orders for Additional Materials and Batches

      (a) In the event that Advancis desires reasonable quantities of Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches in addition to the amount thereof set forth in the Development and Technology Transfer Plan, Advancis shall submit orders to Clonmel specifying the amount of additional Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches (the “Additional Materials and Batches”) and the requested delivery date therefor which shall be mutually agreed to by the Parties. Clonmel shall supply Additional Materials and Batches in accordance with the order. It is expressly understood that Advancis may obtain Clinical Materials, Site Specific Stability Batches and Validation Batches from sources other than Clonmel.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

      (b) No term or provision set forth in any order or similar document submitted by Advancis for purposes of ordering Additional Materials and Batches shall be construed to amend or supersede any provision of this Agreement, and any such terms or provisions of any such order are hereby expressly rejected.

      (c) Advancis shall pay Clonmel for such Additional Materials and Batches ordered by Advancis in the amounts set forth in Schedule 5 within [***] days of invoice therefor, which invoice shall be no earlier than date of delivery to the carrier.

      (a) Clonmel warrants that any Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches delivered pursuant to this Agreement shall be manufactured in accordance with the Approved Master Production Record shall be manufactured in accordance with cGMP, and shall conform to the Product Specifications therefor.

      (b) The warranties set forth in this Section 3.1 shall not apply to any Clinical Materials, Site Specific Stability Batches, scale-up, process development and Validation Batches which (i) have been tampered with or altered after delivery to Advancis; (ii) have been subject to misuse, negligence or accident after delivery to Advancis; or (iii) have been stored, handled or used after delivery to Advancis in any manner contrary to Applicable Laws.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

      (a) Advancis warrants that any Material delivered pursuant to this Agreement, by or on behalf of Advancis, for the production of Site Specific Stability Batches and/or Clinical Material shall conform in all material respects to the Material Specifications and shall be manufactured in accordance with cGMP.

      (b) Clonmel warrants that any material used for scale-up, process development and the production of Validation Batches shall conform in all material respects to the Material Specifications and shall be manufactured in accordance with cGMP.

      (a) Clonmel represents and warrants to Advancis as of the Effective Date, as follows:

      (i) Clonmel has the right to enter into this Agreement; and

      (ii) there are no agreements between Clonmel and any Third Party that conflict with this Agreement

(the “Clonmel General Warranties”).

      (a) Advancis represents and warrants to Clonmel as of the Effective Date, as follows:

      (i) Advancis has the right to enter in this Agreement; and

      (ii) there are no agreements between Advancis and any Third Party that conflict with this Agreement

(the “Advancis General Warranties”).

      (a) When a shipment of Clinical Materials, Site Specific Stability Batches and / or Validation Batches is ready for delivery, Clonmel shall notify Advancis and supply Advancis with the required Shipping Documentation. Clonmel shall not ship any shipment of Clinical Materials, Site Specific Stability Batches and / or Validation Batches until the required Shipping Documentation for such shipment has been approved in writing by Advancis.

      (b) Advancis shall have [***] after receipt of each shipment of Clinical Materials, Site Specific Stability Batches and / or Validation Batches (such period, the “Acceptance Period”) to review such shipment and test Clinical Materials, Site Specific Stability Batches and / or Validation Batches therein. If Advancis believes that Clinical Materials, Site Specific Stability Batches and / or Validation Batches do not comply with the Product Warranties, then Advancis shall deliver to Clonmel written notice of rejection (the “Rejection Notice”) of such Clinical Materials, Site Specific Stability Batches and / or Validation Batches, stating in reasonable detail the basis for such assertion of non-compliance. Any Clinical Materials, Site Specific Stability Batches and /or Validation Batches not rejected within such [***] period shall be deemed to be accepted by Advancis; provided, however, that Advancis thereafter may send a Rejection Notice for Clinical Materials and/or Site Specific Stability Batches and/or Validation Batches promptly following the discovery of any failure to comply with the Product Warranties if such non-compliance was not reasonably discoverable within such [***] period (each such non-compliance a “Latent Defect”). If a Rejection Notice is received by Clonmel during the Acc