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Exhibit 10.1
CONFIDENTIAL TREATMENT REQUESTED
AMENDED DEVELOPMENT AND LICENSE
AGREEMENT
DEPOMED, INC.
AND :
BIOVAIL LABORATORIES
INCORPORATED
THE SYMBOL “[**]” IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Contents
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AMENDED DEVELOPMENT AND LICENSE
AGREEMENT
THIS AMENDED AGREEMENT is made as of the 27 th day of April, 2004, by and between
DEPOMED, INC.
(Hereinafter referred to as “DepoMed”)
AND:
BIOVAIL LABORATORIES
INCORPORATED
(Hereinafter referred to as “BLI”)
RECITALS
A. DepoMed is the owner of original processes, patents and know-how for the development and manufacture of oral drug delivery systems which form the basis of the Licensed Product (as defined herein);
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B. BLI is the owner or licensee of original processes, patents and know-how for the development and manufacture of oral drug delivery systems which form the basis of the BLI Metformin Product (as defined herein);
C. DepoMed and BLI are parties to that certain Development and License Agreement, dated as of May 28, 2002 (the “ Original Agreement ”);
D. DepoMed has developed and may further develop products using DepoMed’s GR System TM (as defined herein) which, to DepoMed’s knowledge, will be subject to patent protection at least to the extent of the GR System;
E. BLI has developed the BLI Metformin Product;
F. BLI desires to obtain rights and options to market and sell products utilizing the GR System and an active drug component in the Territory;
G. DepoMed desires to permit BLI to use the Regulatory Data for the purpose of obtaining Regulatory Approval of the BLI Metformin Product in the Territory; and
I. DepoMed and BLI desire to amend the License Agreement as set forth herein.
NOW, THEREFORE, in consideration of the agreements and covenants hereinafter set forth herein and intending to be legally bound hereby, the parties hereto covenant and agree as follows:
1. DEFINITIONS .1.1 The terms defined in this Article 1 shall, for all purposes of this Agreement, have the following meanings:
1.2 “ Active Ingredient ” shall mean the chemical compound known as metformin HCl.
1.3 “ Adjusted Percentage ” shall mean the percentage obtained by dividing the aggregate of the amounts set out in Schedule 1.43 for each step in the Work Plan to be conducted after
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the date hereof and successfully completed by DepoMed after the date hereof, by the Development Budget.
1.4 “ Affiliate ” shall mean any corporation or other entity that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with the designated party but only for so long as such relationship exists. For the purposes of this section, “ Control ” shall mean ownership of at least fifty percent (or such lesser percent as may be the maximum that may be owned by foreign interests pursuant to the laws of the country of incorporation) of the shares of stock entitled to vote for directors in the case of a corporation and at least fifty percent (or such lesser percent as may be the maximum that may be owned by foreign interests pursuant to the laws of the country of domicile) of the interests in profits in the case of a business entity other than a corporation.
1.5 “ Amendment Date ” shall mean the date first written on page 1 of this Amended Agreement.
1.6 “ Applicable Permits ” shall mean all permits or approvals necessary to market the Licensed Product in the United States or Canada, including, without limitation, Regulatory Approvals granted by the FDA and the TPD
1.7 “ BLI Delivery System ” shall mean the oral controlled release tablet matrix technologies used by BLI to develop the BLI Metformin Product.
1.8 “ BLI Metformin Product ” shall mean a once daily oral tablet formulation of the Active Ingredient in a 1000 mg strength using the BLI Delivery System.
1.9 “ BLI Patent Rights ” shall mean any patent application or issued patent covering BLI Metformin Product or any improvement to BLI Metformin Product or any methods for making or using BLI Metformin Product or any improvement to such methods, which patents or patent applications are owned by or licensed to BLI or any of its affiliates as of the Amendment Date or which are developed or acquired by or licensed to BLI or any of its Affiliates during the term of this Agreement, in any jurisdiction outside the Territory,
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including any addition, continuation, continuation-in-part, or division thereof or any substitute application thereof, any reissue or extension of any such patent, and any confirmation patent, registration patent revalidation patent, or patent of addition based on any such patent, and includes without limitation the United States patents and patent applications, and foreign patents and applications set forth in Schedule 1.9.
1.10 “[**]” means [**].
1.11 “ Change in Control ” with respect to DepoMed shall mean an event whereby:
(a) any person or group (as defined in Section 13(d)(3) or 14(d)(2) of the Exchange Act) other than BLI or an Affiliate of BLI has become the direct or beneficial owner (as defined in Rule 13d-3 under the Exchange Act) of more than 20% of the voting stock of DepoMed, or
(b) DepoMed is merged with or into or amalgamated or consolidated with another corporation other than BLI or an Affiliate of BLI and the stockholders of DepoMed, immediately prior to such amalgamation, consolidation, or merger, own less than eighty per cent (80%) of the voting stock of the surviving corporation immediately after such transaction.
1.12 “Application for Regulatory Approval” means an application made to a Regulatory Authority in any country for permission to Market a pharmaceutical product in that country, and includes a New Drug Application (an “NDA”) and an Abbreviated New Drug Application (an “ANDA”).
1.13 “ Clinical Information ” means all in-vivo or clinical, pharmacology, toxicology, safety and efficacy data, formulary submissions, pharmaco-economic data, Phase I, II and III clinical data and results, and other such information now or hereafter known and available to DepoMed or BLI or their Affiliates, whether generally known to others or not, relating to the Licensed Product .
1.14 “Develop” shall mean to perform all of the work set out in the Work Plan and this Agreement, and “Developed” and “Development” have corresponding meanings.
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1.15 “Development Budget” means the total cost of the Development work set out in the Work Plan minus the amounts shown in the Work Plan as having been incurred prior to the date hereof.
1.16 “Development Review Team” means the development review team established pursuant to section 2.11.
1.17 “ Effective Date ” shall mean the date upon which the waiting period (and any extension thereof) under the HSR Act applicable to the transactions contemplated by this Agreement shall have been terminated or shall have expired..
1.18 “ FDA ” shall mean the United States Food and Drug Administration or any successor United States governmental agency performing similar functions with respect to pharmaceutical products.
1.19 “ Final Judgment” shall mean a judgment by a court of competent jurisdiction that is unappealed (and the time for appealing has expired) or is unappealable.
1.20 “ GR System ” shall mean DepoMed’s delivery system designed to be retained in the stomach for an extended period of time while that delivery system delivers the incorporated drug or drugs, and includes the delivery system described in the patents and patent applications listed in Schedule 1.32 and any and all improvements to that delivery system.
1.21 “ HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
1.22 “ Invention ” means the Licensed Product, any improvement to the Licensed Product, any new use of the Licensed Product, any new performance characteristic of the Licensed Product, any new process used to Manufacture the Licensed Product, or any step or steps in any such process, and includes all formulations of the Licensed Product Developed pursuant to this Agreement.
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1.23 “ Know-How ” shall mean all inventions, discoveries, trade secrets, improvements and information not in the public domain, whether or not patented or patentable (but excluding Patent Rights), together with all experience, data, formulas, procedures and results, and improvements thereon, now or hereafter developed or acquired by and proprietary or licensed with right to sublicense to DepoMed on the date hereof or which are developed or acquired during the term of and in connection with this Agreement, which relate to or are used in conjunction with the development, manufacture or use of Licensed Product.
1.24 “ Knowledge ” or “ knowledge ” shall mean, with respect to DepoMed, the actual knowledge of the executive officers of DepoMed, after reasonable inquiry directed to such employees of DepoMed who would reasonably be expected to have knowledge of relevant matters.
1.25 “ Licensed Product ” shall mean a once daily oral formulation of the Active Ingredient in combination with the GR System.
1.26 “ Manufacture ” means to process, prepare, make, and analyze, and Manufacturing and Manufactured have a corresponding meaning.
1.27 “ Market ” means to promote, distribute, package, label, market, advertise, sell or offer to sell, and Marketing has a corresponding meaning.
1.28 “ NDA ” shall mean a New Drug Application or equivalent application for approval to market submitted to the FDA.
1.29 “ Net Sales ” shall mean the total of all amounts invoiced by BLI and its Affiliates for Licensed Product and BLI Metformin Product sold to independent, unrelated third parties in the Territory in bona fide arms-length transactions, less the following deductions actually allowed and taken by such third parties and not otherwise recovered by or reimbursed to BLI or its Affiliates: (i) trade, cash and quantity discounts in such amounts as are customary in the trade; (ii) rebates, credits or other reimbursements actually paid; (iii) taxes on sales (such as sales or use taxes) to the extent added to the sales price and
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set forth separately as such in the total amount invoiced; (iv) value added taxes when included as part of the sales price and not refunded to the payor; (v) freight, insurance, and other transportation charges to the extent added to the sales price and set forth separately as such in the total amount invoiced; and (vi) amounts repaid or credited by reason of rejections, defects or returns or because of retroactive price reductions. Net Sales shall not include sales of a Licensed Product or a BLI Metformin Product between or among BLI and its Affiliates, or from BLI or an Affiliate of BLI to a sub-licensee, and shall not include Sub-Licensee Net Sales.
1.30 “ Orange Book ” shall mean the “Approved Drug Products with Therapeutic Equivalence Evaluations” publication of the FDA.
1.31 “ Party ” shall mean DepoMed or BLI, and Parties shall mean DepoMed and BLI.
1.32 “ Patent Rights ” shall mean any patent application or issued patent covering Licensed Product or any improvement to Licensed Product or any methods for making or using Licensed Product or any improvement to such methods, which patents or patent applications are owned by or licensed to DepoMed as of the date hereof or which are developed or acquired by or licensed to DepoMed during the term of this Agreement, in the Territory, including any addition, continuation, continuation-in-part, or division thereof or any substitute application thereof, any reissue or extension of any such patent, and any confirmation patent, registration patent revalidation patent, or patent of addition based on any such patent, and includes without limitation the United States patents and patent applications, and foreign patents and applications set forth in Schedule 1.32.
1.33 “ Regulatory Data ” shall mean all information and data necessary to obtain or maintain Regulatory Approval for Licensed Product in the Territory, including post-approval reports, filings and submissions and shall include, but not be limited to, any Clinical Information required for that purpose.
1.34 “Regulatory Approval” shall mean the permission or consent granted by any relevant Regulatory Authority for the Marketing of a Product in the BLI Territory, and includes all
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of the contents of the Application for Regulatory Approval as approved by that Regulatory Authority.
1.35 “Regulatory Authority” shall mean, in respect of any country, any government or other agency responsible for the issuance of approval to Market pharmaceutical products in or sold from that country, including without limitation the FDA.
1.36 “ Sub-Licensee Net Sales ” shall mean the total of all amounts invoiced by a sublicensee of BLI for sales of Licensed Product and BLI Metformin Product to independent, unrelated third parties in bona fide arms-length transactions, less the following deductions actually allowed and taken by such third parties and not otherwise recovered by or reimbursed to that sublicensee: (i) trade, cash and quantity discounts in such amounts as are customary in the trade; (ii) rebates, credits or other reimbursements actually paid; (iii) taxes on sales (such as sales or use taxes) to the extent added to the sales price and set forth separately as such in the total amount invoiced; (iv) value added taxes when included as part of the sales price and not refunded to the payor; (v) freight, insurance, and other transportation charges to the extent added to the sales price and set forth separately as such in the total amount invoiced; and (vi) amounts repaid or credited by reason of rejections, defects or returns or because of retroactive price reductions.
1.37 “ Substitute Product ” means any once daily oral formulation containing between 480 mg and 520 mg of Active Ingredient and utilizing technology other than the GR System and that does not infringe a Valid Claim of the Patent Rights, for which Regulatory Approval is obtained by way of a supplement or an amendment to the NDA filed for the Licensed Product.
1.38 “ Technical Information ” shall mean all Know-How, and all trade secrets, inventions, data and technology relating to the Licensed Product, and any improvements and modifications to any of the foregoing, and includes, without limitation, processes and analytical methodology used in the development, testing, analysis and manufacture of the Licensed Product., and medical, clinical, toxicological and other scientific data relating to the Licensed Product.
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1.39 “ Territory ” shall mean all the United States of America (including Puerto Rico) and Canada.
1.40 “ Toxicology Studies ” means any toxicology studies that have been conducted by or for BLI with respect to the Active Ingredient.
1.41 “ US GAAP ” shall mean accounting principles generally accepted in the United States of America.
1.42 “ Valid Claim ” shall mean a claim of an unexpired issued patent falling within Patent Rights, which claim shall not have been withdrawn, cancelled, disclaimed or held invalid by a court, tribunal, arbitrator or governmental agency of competent jurisdiction in a final or unappealed or unappealable decision.
1.43 “ Work Plan ” shall mean a statement of the purposes, activities and goals to be utilized and performed in Developing a 500 mg strength of the Licensed Product, identifying the tasks and obligations to be undertaken by DepoMed and the timetable within which it is contemplated that DepoMed will complete each of those tasks and obligations, as the same may from time-to-time be refined by the DRT in accordance with this Agreement. The Work Plan as of the date hereof is attached hereto as Schedule 1.43.
2. PRODUCT DEVELOPMENT
2.1 DepoMed shall, at its own expense but subject to the provisions of section 4.2, use diligent efforts (i) to carry out its obligations under this Agreement and the Work Plan to Develop a 500 mg strength of the Licensed Product, and (ii) to the extent specified in the Work Plan, design and undertake any required analytical testing and clinical studies.
2.2 BLI acknowledges that DepoMed has commenced the Development of the Licensed Product prior to the Effective Date. All of the obligations of DepoMed under this Agreement or any Work Plan referred to in this Agreement shall commence as soon as reasonably possible, but no later than sixty (60) days, after the Effective Date. DepoMed
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shall use diligent efforts to carry out such obligations in accordance with the time limits set out in the Work Plan. The Parties recognize that the time frames in the Work Plan include “Target Dates” and “Assumptions” and may be dependent on FDA actions.
2.3 DepoMed shall follow any direction and guidelines provided by the DRT, (provided such directions and guidelines are not inconsistent with the applicable Work Plan or this Agreement) in the Development of a 500 mg strength of the Licensed Product.
2.4 DepoMed shall be responsible for obtaining, at its own expense, all materials, supplies and resources required for the Development of a 500 mg strength of the Licensed Product in accordance with this Agreement and the Work Plan.
2.5 DepoMed shall develop all of the analytical and clinical protocols that have not already been developed and that are required for Regulatory Approval of the Licensed Product, and shall provide copies of any such protocols to the DRT for review and approval before the commencement of any test or study in which that protocol is to be used. DepoMed shall conduct any tests or studies required by this Agreement or by the Work Plan only in accordance with protocols approved by the DRT.
2.6 DepoMed shall use diligent efforts to develop and validate all necessary analytical methods not already developed for the Licensed Product, and shall disclose those to the DRT for review and approval before use. BLI shall, at the request of DepoMed, provide to DepoMed any validated analytical methods known to BLI and that BLI may determine are useful in the development of the Licensed Product, but DepoMed shall not be obliged to use any such method unless DepoMed is unable to develop and validate any required analytical process.
Subcontracted Tests and Studies
2.7 None of the tests or studies required by the Work Plan, excluding those already sub-contracted, shall be sub-contracted by DepoMed unless the sub-contract is approved by the DRT. Provided that BLI or any contract research organization designated by BLI is
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capable of conducting any tests or studies required by the Work Plan within a time period set out in the Work Plan, DepoMed shall arrange for all of such studies to be conducted at the contract research facilities of BLI or such designated contract research organization. DepoMed shall not be responsible for any deficiencies or defects in any studies conducted by a contract research organization designated by BLI pursuant to this section, or for any delays in the filing of an Application for Regulatory Approval caused by or arising from the use of any such contract research organization.
DepoMed Facilities and Employees
2.8 DepoMed shall use commercially reasonable efforts to ensure that any facilities at which all or part of the Development of the 500 mg strength of the Licensed Product is conducted complies with all required GMP Standards.
2.9 DepoMed shall use commercially reasonable efforts to ensure that any employee or sub-contractor of DepoMed to whom any Development work is assigned or sub-contracted is competent to perform the tasks assigned or sub-contracted at the time of such assignment or sub-contract, and shall at the request of the DRT replace any employee or sub-contractor determined on reasonable grounds by the DRT to lack the skills, competence or experience necessary to perform the Development work required.
2.10 DepoMed shall bear the cost of any Development work that must be repeated because the facilities at which the work was conducted did not comply with all required GMP standards, or because the work was assigned or sub-contracted to persons who were not competent to do that work.
2.11 DepoMed and BLI shall within seven (7) days after the date hereof establish a Development Review Team (“ DRT ”), consisting of up to three representatives of DepoMed and up to three representatives of BLI. One of the DepoMed members, chosen at the sole discretion of DepoMed, shall serve as chair of the DRT.
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2.12 Regardless of the number of representatives from each party on the DRT, each Party shall present one consolidated view and, subject to the provisions of section 2.18, shall have one vote on any issue in dispute. All decisions of the DRT shall be made by majority vote. Each member of the DRT shall ensure that any issue for decision by the DRT has received the prior review and written approval of any appropriate internal management committees of the Party that he or she is representing on the DRT and shall be deemed to have all necessary authority to act and to vote on behalf of that Party. If the DRT fails to decide any matter before it for consideration in the manner required by this section, the matter shall be submitted to the Chief Executive Officer of DepoMed and the President of BLI for resolution. Any disputes within the DRT that remain unresolved after discussion between the Chief Executive of DepoMed and the President of the BLI, shall be resolved by the Chairman of BLI, acting in the best interests of the Development of the Licensed Product.
2.13 Meetings of the DRT shall be held at least quarterly, or more frequently as mutually agreed upon, or whenever called by either DepoMed or BLI with not less than ten (10) days notice to the other Party unless such notice is waived, unless no later than thirty (30) days in advance of any meeting there is a determination by the DRT that no new business or other activity has transpired since the previous meeting, and that there is no need for a meeting. The DRT may, by mutual agreement, convene by means of telecommunication, video-conference or face-to-face meetings. The location of any face to face meetings shall alternate between the facilities of BLI’s Affiliate in Chantilly, Virginia, and the DepoMed facility in Menlo Park, California. DRT Each of DepoMed and BLI shall disclose to the other proposed agenda items reasonably in advance of each meeting of the DRT. Each of DepoMed and BLI shall bear its own costs for participation in the DRT.
2.14 The first meeting of the DRT shall occur within seven (7) days after the date hereof for the purpose of supplementing all of the necessary details to the Work Plan, and to approve any protocols that have been submitted by for approval by the DRT at that time.
2.15 At each meeting of the DRT, the DRT shall review the Development of the Licensed Product to date, and shall determine if any adjustments or refinements to the Work Plan
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are required. At each such meeting, the DRT shall review and approve the Development work to be carried out by DepoMed, and the protocols to be used in that Development work, in the calendar quarter following that meeting.
2.16 Minutes of each DRT meeting shall be transcribed and issued by the Chairman or his designee within fifteen (15) days after each meeting and shall be approved as the first order of business at the immediately succeeding DRT meeting.
2.17 DepoMed shall not be responsible for any delays or increased costs experienced or incurred in the Development of the Licensed Product as a consequence of a decision of the Chairman of BLI or his designate inconsistent with the views of DepoMed on that issue.
Change in Contro l of DepoMed
2.18 Notwithstanding the provisions of sections 2.11 to 2.17, BLI shall have the right, upon any Change in Control of DepoMed, to appoint an additional voting member to the DRT, and upon that appointment, BLI shall have two votes and DepoMed shall have one vote.
3. TERMINATION OF DEVELOPMENTInability of DepoMe d to Continue Development
3.1 BLI may, by notice in writing to DepoMed, assume responsibility for the Development of the Licensed Product under the Work Plan if there is a Change in Control of DepoMed, or if BLI determines, in good faith, that DepoMed is unable to complete the Work Plan, except for any inability due to lack of funding available to DepoMed, to the satisfaction of BLI, or to Develop the 500 mg strength of the Licensed Product capable of receiving Regulatory Approval. BLI shall thereafter use diligent efforts to carry out the obligations of DepoMed under this Agreement and the Work Plan to Develop a 500 mg strength of the Licensed Product. DepoMed shall continue to fund the Development of the Licensed Product to the extent otherwise required by this Agreement, to the limit of the Development Budget.
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Failure of DepoMed to Fund the Development
3.2 If DepoMed fails:
(a) to carry out its obligations under the Work Plan, including the trial protocols, and the target dates set out in the first three pages of the Work Plan but excluding any time limits in those trial protocols; or
(b) to fund the Development of the 500 mg strength of the Licensed Product; or
(c) to fulfill its obligations under sections 2.1, 2.3, 2.4, 2.7, 6.1, 6.2 and 6.4 of this Agreement,
BLI, acting reasonably, but without affording DepoMed any time otherwise provided by this Agreement to cure any breach of this Agreement, may on notice in writing to DepoMed, assume responsibility for the Development of the Licensed Product and carry out those obligations, or engage a qualified third party to carry out those obligations, all at BLI’s expense.
3.3 Upon the delivery by BLI to DepoMed of a notice pursuant to Section 3.2, DepoMed shall assign to BLI any assignable contracts that DepoMed may have with any contract research organization under which any of the Development work is being conducted. BLI shall have no responsibility or liability for any such contracts that are not assigned to BLI.
4. PRODUCT DEVELOPM ENT COSTS4.1 In consideration of the entering into of this Agreement by BLI, and the agreement by BLI to make the license payment required by Article 9 of this Agreement, and to pay the royalties required by section 12 of this Agreement, DepoMed agrees to carry out its obligations under this Agreement and the Work Plan for the Licensed Product after the Effective Date, as that Work Plan may be adjusted pursuant to section 2.15 of this Agreement.
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4.2 Any costs required to obtain Regulatory Approval of the Licensed Product in the Territory other than the costs to be incurred by DepoMed under this Agreement and the Work Plan shall be paid by BLI.
5. DISCLOSURE OF INFORMA TION AND REPORTING5.1 Upon execution of this Agreement and thereafter during the term hereof, each Party shall disclose to the other, in confidence under the terms of Article 8 hereof, Technical Information and Clinical Information, and copies of correspondence with any Regulatory Authority, as the same shall become available, including information and correspondence relating to the safety and efficacy of Licensed Product and any regulatory problems relating thereto, all to the extent necessary or useful to enable the receiving party to Develop, Manufacture or Market the Licensed Product in accordance with its obligations under this Agreement.
5.2 DepoMed shall deliver to BLI, within fourteen (14) days after any request of BLI for information about the Development of the Licensed Product, a written report setting out the steps taken by DepoMed to Develop the Licensed Product, and summaries of any tests or studies conducted by DepoMed on the Licensed Product since the last such report was delivered to BLI, and a comparison of the progress made in the Development of the Licensed Product against the Work Plan.
5.3 DepoMed shall deliver to BLI every ninety (90) days during the Development of the Licensed Product, at least seven (7) days in advance of each regularly scheduled meeting of the DRT, a written report setting out the steps taken by DepoMed to Develop the Licensed Product, summaries of any tests or studies conducted by DepoMed and all Clinical Information generated since the last such report was delivered, and a comparison of the progress made in the Development of the Licensed Product against the Work Plan. DepoMed shall provide to BLI those portions of any internal R&D report dealing with the Licensed Product.
5.4 DepoMed shall provide to BLI copies of all material correspondence, including correspondence with any Regulatory Authority, contracts with third parties including
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contract research organizations, and reports relating to the Development of the Licensed Product received by DepoMed from any contract research organization engaged by DepoMed to conduct any tests or studies relating to the Development of the Licensed Product, as soon as reasonably possible, but no later than fifteen (15) days, after receipt of such correspondence or reports by DepoMed.
5.5 DepoMed shall complete the product development report required for an Application for Regulatory Approval within ten (10) months after the successful completion of the Work Plan.
Records and Reports.
5.6 DepoMed shall maintain records, in sufficient detail and in compliance with GMP Standards and generally accepted accounting principles, and for a period of three (3) years after the completion of the Work Plan, which records shall fully and properly reflect all work done, and all results achieved by DepoMed in the performance of its obligations under this Agreement. Upon request, DepoMed shall provide copies of these records to BLI at BLI’s cost. BLI shall have the right, not more frequently than once per month, during normal business hours and upon one week’s notice, to inspect and copy all such records of DepoMed.
5.7 BLI shall have the right to arrange for its employees and/or consultants involved in the activities contemplated hereunder to visit DepoMed at its offices and laboratories during normal business hours and upon one week’s notice, and to discuss the Work Plan, the progress of the Development work, its results, and the data and information generated, with the technical personnel and consultants of DepoMed.
5.8 Any report or protocol required by this Agreement to be approved by BLI shall be deemed to be approved by BLI upon the expiry of thirty (30) days from the date of delivery to BLI, unless BLI has within those thirty (30) days advised DepoMed of any defects or deficiencies in that report or protocol. BLI may designate any third person to inspect, under confidentiality, any such report or protocol, at BLI’s expense.
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6. INFORMATION FOR REGULATORY APPROVAL6.1 DepoMed shall develop, and provide to BLI, all Technical Information relating to the Licensed Product that may be reasonably necessary to enable BLI to complete the CMC Section for the Licensed Product. Any such information that DepoMed has in its possession at the Effective Date shall be provided within sixty (60) days after the Effective Date, or within such other time that the DRT may set, and thereafter such Technical Information shall be provided within twenty (20) Business Days of the acquisition or development of such information. Such information shall include, without limitation:
(a) all manufacturing procedures and processes used to manufacture the Clinical Batches, including a copy of each master batch record used to manufacture the Clinical Batches, raw material lists and specifications, equipment lists and specifications;
(b) master formula describing quantitative composition of all active and inactive components used to manufacture the Clinical Batches, together with the specifications for each component;
(c) all in vitro and in vivo test methodologies, method validations, test results and product specifications generated by DepoMed in connection with the manufacture of the Clinical Batches;
(d) all reports of stability studies conducted by DepoMed in connection with the manufacture of the Clinical Batches; and,
(e) all other data and information in the possession of or available to DepoMed and required by or reasonably useful to BLI in the preparation of an Application for Regulatory Approval.
6.2 DepoMed shall deliver to BLI within sixty (60) days after the Effective Date, for each of the Clinical Batches of the Licensed Product, and in a form reasonably acceptable to BLI:
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(a) a GMP certificate duly prepared and signed by a senior quality assurance of compliance officer of DepoMed; and
(b) any letters of access required to permit the FDA or any other Regulatory Authority in the Territory to access any drug master files or site reference files relating to the Licensed Product for the purpose of reviewing any Application for Regulatory Approval of the Licensed Product in the Territory; and
(c) a Site Reference File for the DepoMed Facility at which the Clinical Batches for the Licensed Product were prepared; and
(d) any other information related to the Licensed Product which is in the possession or control of DepoMed and is required for an Application for Regulatory Approval.
6.3 DepoMed shall provide to BLI such assistance as BLI may reasonably require in the preparation of the CMC Section of an Application for Regulatory Approval of the Licensed Product.
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AGREEMENTS / CONTRACTS
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