Development Program. (a) Promptly following execution of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000. In the course of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 hereto, take appropriate steps including the following: (i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION; (ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES. (b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, and shall take such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld. (c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONS.
Appears in 2 contracts
Sources: Development and License Agreement (Ilex Oncology Inc), Development and License Agreement (Ilex Oncology Inc)
Development Program. (a) Promptly following execution of this LICENSE AGREEMENTRWJPRI shall be solely responsible for and have the exclusive right, ILEX shall use at its best efforts based on ILEX's reasonable business judgmentdiscretion but in consultation with the JDAC, to execute select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the exclusive right to develop the PRODUCT through STAGES O, I, II and III and shall have the exclusive right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000established by RWJPRI. In the course of such efforts ILEX RWJPRI shall, under either directly or through an AFFILIATE or SUBLICENSEE to which the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 heretolicense shall have been extended, take appropriate steps including the following:
(i) Establish in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to complete PHASE III obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials on the LICENSED PRODUCT for the LEAD INDICATION;of such PRODUCT.
(iiiii) Proceed proceed following successful completion of IND non-rejection to commence PHASE I, II, and III clinical trials, other associated studies and all such other work which the PMT RWJPRI reasonably deems to be required, to prepare and compile the necessary regulatory documentation required for subsequent inclusion in a filing of filings for MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.AUTHORIZATION;
(biv) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, and shall take after such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be submissions are filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary all reasonably necessary, reports and responses respond to all reasonable requests fromt he from the pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h regulatory, authorities for information, data, samples, tests and the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONSlike.
Appears in 2 contracts
Sources: Research and License Agreement (Kosan Biosciences Inc), Research and License Agreement (Kosan Biosciences Inc)
Development Program. Subject to Bukwang’s timely performance of its obligations hereunder, and in complete fulfillment of Triangle’s diligence obligations hereunder and any such obligations implied by law, Triangle will undertake, or, if applicable, will cause its Affiliates and sublicensees to undertake, the development activities described in this Article 6. Triangle shall, at its expense, use its [BUKWANG REDACTED] (a) Promptly following execution to conduct a development program (the “Development Program”) relating to the use of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgmentthe Licensed Product for HBV and (b) if the results of the Development Program so justify, to execute the DEVELOPMENT PLAN and to carry out the activities seek Registration for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT such Licensed Product in the United States and Europe no later than the 13 second quarter States. As part of the year 2000Development Program, Triangle shall be responsible for conducting 3-month toxicity studies in two species of animals pursuant to protocols which it develops or approves, as applicable. In Triangle shall commence both toxicity studies as promptly as practicable [BUKWANG REDACTED] after it obtains Bulk Drug Substance of a quality and in such quantities reasonably necessary to perform such toxicity studies. Bulkwang shall promptly reimburse Triangle for [BUKWANG REDACTED] of the course out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated out-of-pocket costs. The Development Program shall be mutually discussed by the PMT as set forth in parties hereto at the meetings of the Joint Project Committee held pursuant to Article 3.1.2 hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, 7 and shall take such steps as it deems necessaryinto consideration studies and experiments carried out, or to be carried out by, Bukwang and its licensees, if any, outside the Territory, but the activities within the Territory comprising the Development Program shall be determined at Triangle’s sole discretion. Anything in order this Agreement to perform its obligations in accordance with the terms hereof. ILEX contrary notwithstanding, Triangle shall use its best based on its reasonable be entitled to exercise prudent and justifiable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedulemeeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld[BUKWANG REDACTED].
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONS.
Appears in 2 contracts
Sources: License Agreement (Pharmasset Inc), License Agreement (Pharmasset Inc)
Development Program. (a) Promptly following execution of this LICENSE AGREEMENT, ILEX RWJPRI shall use its best efforts based on ILEX's reasonable business judgmentbe [**] and have [**] in consultation with the JDAC, to execute select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000established by RWJPRI. In the course of such efforts ILEX RWJPRI shall, under either directly or through an AFFILIATE or SUBLICENSEE to which the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 heretolicense shall have been extended, take appropriate steps including the following:
(i) Establish in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to complete PHASE III obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials on the LICENSED PRODUCT for the LEAD INDICATION;of such PRODUCT.
(iiiii) Proceed proceed following successful completion of IND non-rejection to commence PHASE I, II, and III clinical trials, other associated studies and all such other work which the PMT RWJPRI reasonably deems to be required, to prepare and compile the necessary regulatory documentation required for subsequent inclusion in a filing of filings for MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.AUTHORIZATION;
(biv) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, and shall take after such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be submissions are filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary all reasonably necessary, reports and responses respond to all reasonable requests fromt he from the pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h regulatory, authorities for information, data, samples, tests and the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONSlike.
Appears in 2 contracts
Sources: Research and License Agreement (Kosan Biosciences Inc), Research and License Agreement (Kosan Biosciences Inc)
Development Program. (a) Promptly The following execution Section of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT Article 3 of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000. In the course of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 hereto, take appropriate steps including the followingAgreement shall be amended:
(i) Establish SB agrees to deliver to Aphton anti-GnRH conjugate manufactured under contract for SB (hereafter the "Conjugate") at no expense to Aphton within sixty (60) days of the acceptance of an amended Development Plan by the Steering Committee (the date of said delivery hereafter termed the "Delivery Date"). The Steering Committee shall either accept or reject the amended Development Plan within thirty (30) days of submission by Aphton to the Steering Committee, which shall happen no later than sixty (60) days after the Execution Date. Such submission shall include the immunogen development program up to presentation by Aphton to the Steering Committee in accordance with Section 3.1(ii) below. SB shall deliver quantities of the Conjugate sufficient to carry out the amended Development Plan as approved by the Steering Committee, and maintain a program reasonably designedif so decided by the Steering Committee SB shall deliver reasonable additional quantities of the Conjugate as approved by the Steering Committee at any later time. The parties agree to replace the Development Plan contained in Schedule B of the Agreement with the amended Development Plan, funded and resourced to complete PHASE III trials on as approved by the LICENSED PRODUCT Steering Committee. The Development Program Term shall be amended accordingly. Except for the LEAD INDICATION;costs associated with the manufacturing of the Conjugate, Aphton shall be responsible for funding all costs for research and development relating to Aphton's Product (including formulations in SB's Adjuvant Technology) to be presented to the Steering Committee in accordance with paragraph (ii) below.
(ii) Proceed following successful completion Aphton shall present its Product to the Steering Committee for acceptance. (The date on which Aphton first presents its Product to the Steering Committee shall hereafter be termed the "Presentation Date.") The Steering Committee shall have sixty (60) days to accept or reject Aphton's Product. Failure by the Steering Committee to either accept or reject Aphton's Product within sixty (60) days of PHASE III trialsthe Presentation Date shall be considered a rejection by the Steering Committee. If the Steering Committee rejects Aphton's Product, the parties may agree that Aphton will be allowed to conduct additional research and development and make a subsequent presentation to the Steering Committee for acceptance. In no event shall the Presentation Date be later than [Redacted]*. After the Steering Committee has accepted Aphton's Product (hereafter termed the "Acceptance Date"), SB shall undertake the further development of the Product under the amended Development Plan (other associated studies than the immunogen development) and shall be responsible for funding all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS costs (as previously defined in the United States and Europe for Agreement). The Development Program can be amended and/or complemented from time to time by the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIESSteering Committee.
Section 3.1 (biv) In carrying out shall be complemented as follows: During the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of Development Program Term and any extension thereof Aphton undertakes to (i) use best efforts to materially perform all its scientific, engineering, manufacturing and other personnel specified activities in the DEVELOPMENT PLAN, Development Program (ii) and shall take such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its all reasonable business judgment efforts to carry out achieve its objectives under the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheldDevelopment Program.
Section 3.1 (cv) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries complemented as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONS.follows:
Appears in 1 contract
Development Program. A. Angeion shall complete at no additional charge development of the Spot Catheter Product in accordance with the specification as set forth in Exhibit A for clinical studies to support a Pre-Market Approval (a"PMA") Promptly following execution submission. Any changes to the specification for the Spot Catheter Product reasonably requested by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ after the Effective Date shall be completed by Angeion and paid for by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ on a time and materials basis at the Development Rates as set forth in Exhibit B.
B. Angeion shall develop Linear Catheter Product concept prototypes in accordance with a project plan to be agreed upon by the parties. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ shall select a Linear Catheter Product from the concept prototypes and the parties shall agree upon a project plan and specifications for the selected concept prototype of this LICENSE AGREEMENTthe Linear Catheter Product. Development of the selected concept prototypes of the Linear Catheter Product shall include design, ILEX building and testing of prototypes and clinical units for PMA submission, equipment modifications and in vitro testing, when required.
C. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ will fund Angeion for reasonable costs incurred commencing January 1, 1998 to produce the concept prototypes and develop the selected concept prototype for the Linear Catheter Product (including not more than [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]incurred as of the Effective Date as set forth in the invoice attached as Exhibit C) in accordance with a budget of up to [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] and a set of milestones to be agreed by the parties as part of the project plan. Angeion shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT complete development of the LICENSED PRODUCT so that JANSselected concept prototype of the Linear Catheter Product in accordance with the budget and milestones and shall not incur additional charges or costs above the agreed upon budget without prior written approval of ▇▇▇▇▇▇ ▇▇▇ launch ▇▇▇▇▇; however, the LICENSED PRODUCT budget shall be based funding Angeion on a time and materials basis at the Development Rates as set forth in Exhibit B. Angeion does not guarantee or warrant that the United States and Europe no later than development work related to the 13 second quarter selected concept prototype of the year 2000Linear Catheter Product can be completed [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. In All sums paid pursuant to subparagraph C of this section will be paid upon receipt of a statement of services performed. Angeion shall keep accurate records reflecting the course of such efforts ILEX shall, under development work related to the direction of JANSLinear Catheter Product. ▇▇▇▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, and shall take such steps as it deems necessary, in order to perform its obligations in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇▇▇▇ shall have the right to control audit the invoices and direct performance to inspect such records of the DEVELOPMENT PLAN through the PMT, Angeion no more than twice a year during normal business hours and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheldupon reasonable notice.
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated D. Notwithstanding the provisions of paragraph III.C above, it is understood that during the FULL DEVELOPMENT program. At JANSterm of this Agreement ▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇▇ may elect to bring within the ▇▇▇▇▇▇ ▇▇▇ll exercise reasonable efforts▇▇▇▇ organization certain or all of the development and manufacturing activities relating to the Linear Catheter Product as set forth in paragraph III.C and to terminate such activities by Angeion. Prior to such transfer of activities, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇▇▇▇ ▇▇▇ms appropriate▇▇▇▇ shall give Angeion sixty (60) days written notice of its intentions. JANSIn such a case, ▇▇▇▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇▇ shall be liable only for charges for all work done or non-cancelable costs committed by Angeion prior to such transfer. Angeion shall exercise diligent efforts to minimize any such non-cancelable costs. E. Project reviews will be conducted on a quarterly basis or more frequently upon request by ▇LEX shall further assist JANS▇▇▇▇▇ ▇▇▇h ▇▇▇▇ commencing the preparation month the agreement is signed. The review will include access by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, if desired, to all design documentation including the Design History File. Angeion will provide detailed monthly status reports including expenses. Angeion will not exceed a monthly expense total as agreed by the parties without prior written approval of supporting data ▇▇▇▇▇▇ ▇▇▇▇▇▇▇.
F. Angeion shall provide overall project leadership to apply develop and manufacture the Spot Catheter Product and Linear Catheter Product. Product priorities for the Spot Catheter Product, and pursue MARKETING AUTHORIZATION APPLICATIONSproduct priorities, features and specifications for the Linear Catheter Product initially will be decided by ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, after discussions with Angeion. Any changes to the project plan or specifications for the Linear Catheter Products shall be agreed upon by both parties in writing.
Appears in 1 contract
Development Program. (a) Promptly following execution of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT in the United States and Europe no later than the 13 second quarter of the year 2000. In the course of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as The initial Development Program set forth in Article 3.1.2 hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLANExhibit C was prepared by BDSI, and shall take such steps be subject to review by and comments from Meda, as it deems necessary, in order approved by the Development Committee within *** of the HSR Date. BDSI shall use Commercially Reasonable Efforts to perform its obligations conduct pre-Governmental Approval Licensed Product development activities in accordance with the terms hereofDevelopment Program, provided that such activities shall not include the activities of Meda with respect to Mexico and Canada contemplated by Section 2.03(b)(i). ILEX shall use its best based on its Notwithstanding the foregoing or any other provision of this Agreement, Meda acknowledges and agrees that (a) the Development Program is experimental in nature; and (b) BDSI does not guarantee that the Development Program will be successful or that Governmental Approval will be obtained for any Licensed Product or indication therefor. During the Term, BDSI may revise the Development Program at any time and from time to time, provided, to the extent reasonably practicable, BDSI provides the Development Committee with a reasonable business judgment efforts opportunity to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 review and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder comment (which approval opportunity shall not be unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS required to be any longer than ***). Meda shall, notwithstanding anything to the contrary, use Commercially Reasonable Efforts to continue development of the Fentanyl Product for each of the First Indication and Non-Cancer Indication following receipt of Governmental Approval therefor, and, if Commercially Reasonable, develop the Fentanyl Product for and seek Governmental Approval of the Fentanyl Product for such other indications as the Parties agree to pursue in addition to the First Indication and Non-Cancer Indication, in a Commercially Reasonable manner intended to maximize the Parties’ collective economic benefit with respect to the Fentanyl Product, including the conduct of post-approval Phase IIIB and Phase IV studies concerning the Fentanyl Product for the First Indication and, if approved by FDA, the Non-Cancer Indication; Meda shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT include BDSI in such countries as JANS▇▇▇ ▇▇▇ms appropriateefforts in a consultative capacity. JANS▇▇▇ ▇▇▇ll prosecute The Parties agree that it is their intent that the above-described continued development be included in the Development Program, provided that the failure of the Development Program to include such submissions and file above-described development shall not limit Meda’s obligations in the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONSpreceding sentence.
Appears in 1 contract
Sources: License and Development Agreement (Biodelivery Sciences International Inc)
Development Program. (aA) Promptly following execution of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgment, to execute the DEVELOPMENT PLAN and to carry out the activities for FULL DEVELOPMENT Upon delivery of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch Development Program Notification to SPECTRx set forth in Section 2.5, ABBOTT shall diligently undertake and pursue all development activities reasonably required in order to submit Regulatory Filings to obtain governmental approvals to market the LICENSED PRODUCT Product in the United States States, major European Union countries, Japan and Europe no later than in the 13 second quarter other countries of the year 2000. In the course of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated by the PMT as set forth in Article 3.1.2 hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLANTerritory, and shall take such steps as it deems necessary, in order to perform its obligations obtain approvals, all in accordance with the terms hereof. ILEX shall use its best based on its reasonable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedule, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇ABBO▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS torical practice. All such development activity shall either be filed by JANSat ABBO▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇'▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANSense and shall be undertaken in accordance with ABBO▇▇'▇ ▇▇▇ll mal procedures for evaluating development projects and the exercise of its reasonable effortsbusiness judgment, commensurate consistent with the efforts it would normally exercise for products of similar potential sales volume custom and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT practice in such countries as JANSthe industry, and ABBO▇▇'▇ ▇▇▇ms appropriatetorical practice in filing of Regulatory Filings, conduct and completion of clinical trials, demonstration of clinical efficacy and commercial feasibility, and obtaining of regulatory approvals.
(B) Any delays in, or failure to complete the Development Program (i) due to the intentional or negligent acts of SPECTRx except activities directed or required by ABBOTT or the [*] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. JANS▇▇▇ ▇▇▇ll prosecute Omitted portions have been filed separately with the Commission. Research Committee; or (ii) because the Product is either determined not to have been shown to be safe or efficacious, or it is determined that additional material, data, or information is needed to determine safety or efficacy; or (iii) because the Product [*]; or (iv) due to events beyond the reasonable control of ABBOTT shall not constitute a failure of diligence by ABBOTT under this Article, nor a breach by ABBOTT of this Agreement provided, however, that no such submissions delay (other than as set forth in this Section 3.1 (B)(1)) shall extend the periods of the time set forth in Section 3.2 of this Agreement. If an event set forth in Section 3.1 (B)(1) delays the submission of a Regulatory Filing or the First Shipment Date, ABBOTT and file SPECTRx shall negotiate in good faith to extend the necessary reports time periods set forth in Section 3.2(A) and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested (B) by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation a period of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONStime commensurate with such delay.
Appears in 1 contract
Sources: Research & Development and License Agreement (Spectrx Inc)
Development Program. Subject to Bukwang's timely performance of its obligations hereunder, and in complete fulfillment of Triangle's diligence obligations hereunder and any such obligations implied by law, Triangle will undertake, or, if applicable, will cause its Affiliates and sublicensees to undertake, the development *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. activities described in this Article 6. Triangle shall, at its expense, use its *** (a) Promptly following execution to conduct a development program (the "Development Program") relating to the use of this LICENSE AGREEMENT, ILEX shall use its best efforts based on ILEX's reasonable business judgmentthe Licensed Product for HBV and (b) if the results of the Development Program so justify, to execute the DEVELOPMENT PLAN and to carry out the activities seek Registration for FULL DEVELOPMENT of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT such Licensed Product in the United States and Europe no later than the 13 second quarter States. As part of the year 2000Development Program, Triangle shall be responsible for conducting 3-month toxicity studies in two species of animals pursuant to protocols which it develops or approves, as applicable. In Triangle shall commence both toxicity studies as promptly as practicable *** after it obtains Bulk Drug Substance of a quality and in such quantities reasonably necessary to perform such toxicity studies. Bukwang shall promptly reimburse Triangle for *** of the course out-of-pocket costs (excluding all drug costs, which shall be the responsibility of Triangle) incurred by Triangle in conducting such toxicity studies, subject to reasonable substantiation by Triangle of such efforts ILEX shall, under the direction of JANS▇▇▇ ▇▇ coordinated out-of-pocket costs. The Development Program shall be mutually discussed by the PMT as set forth in parties hereto at the meetings of the Joint Project Committee held pursuant to Article 3.1.2 hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATION;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel specified in the DEVELOPMENT PLAN, 7 and shall take such steps as it deems necessaryinto consideration studies and experiments carried out, or to be carried out by, Bukwang and its licensees, if any, outside the Territory, but the activities within the Territory comprising the Development Program shall be determined at Triangle's sole discretion. Anything in order this Agreement to perform its obligations in accordance with the terms hereof. ILEX contrary notwithstanding, Triangle shall use its best based on its reasonable be entitled to exercise prudent and justifiable business judgment efforts to carry out the DEVELOPMENT PLAN in accordance with the agreed upon time 14 and event schedulemeeting its *** obligations hereunder. For purposes of this Article 6, in consultation with the PMT. JANS▇▇▇ shall have the right to control and direct performance of the DEVELOPMENT PLAN through the PMT, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld*** .
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by ILEX based on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONS.
Appears in 1 contract
Development Program. 5.1 As soon as practicable following an Ardana Positive Election and a Columbia Positive Election the Parties shall cause the DC to meet to agree the detailed work program for the Second Development Program and the Development Budget for the first Year of the Second Development Program. The Parties agree that in relation to any Clinical Trials to be carried out as part of the Second Development Program:
5.1.1 Ardana shall be the sole sponsor of and for organising any such Clinical Trials to be carried out in the Ardana Territory and for the Development Costs to be paid in respect thereof (arecouping the appropriate share of such Development Costs under the provisions of Clause 5.3) Promptly following execution and Ardana shall make all Regulatory Applications in respect of this LICENSE AGREEMENT, ILEX such Clinical Trials or in respect of any subsequent Marketing Authorisation in the Ardana Territory in its own name;
5.1.2 Columbia shall use be the sole sponsor of and for organising any such Clinical Trials to be carried out in the Columbia Territory and for the Development Costs to be paid in respect thereof (recouping the appropriate share of such Development Costs under the provisions of Clause 5.3) and Columbia shall make all Regulatory Applications in respect of such Clinical Trials or in respect of any subsequent Regulatory Approval in the Columbia Territory in its best efforts based own name. [***]A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.2 Subject to the provisions of Clause 5.1 each Party shall carry out those tasks and parts of the work program for the Second Development Program allocated to it by the DC provided always that neither Party shall be obliged to commit more FTE to the Second Development Program in any Year than determined under Clause 2.2.4.
5.3 The Parties shall be jointly responsible on ILEXa 50:50 basis for all Development Costs incurred by them in carrying out the Second Development Program. Within thirty (30) days of the end of each Quarter each party shall supply the other with a report of the Development Costs paid by it during that Quarter which report shall set out the tasks undertaken (which tasks shall be cross-referenced to the Second Development Program) and the Development Costs paid in relation to such task. Within forty-five (45) days of the end of each Quarter there shall be a reconciliation prepared of the Development Costs incurred during such Quarter by the Parties which reconciliation shall be in the form of an invoice from one Party to the other Party and a balancing payment as necessary by such Party to the other shall be made so that each Party has borne 50% of the Development Cost for that Quarter. For the avoidance of doubt it is declared and agreed that the sharing of Development Costs shall commence from the point that each Party makes a positive election pursuant to Clause 4 and the Parties acknowledge and agree that subject to the provisions of Clause 3.3 any costs and expenses incurred prior to that date are not chargeable to Development Costs.
5.4 If at the time that the DC seeks ratification of the Development Budget for any Year during the Second Development Program or the FTE commitment for any Year it is not so ratified by either Party's Chief Executive Officer in writing within 3 months of the commencement of the Year to which it relates (such Party's reasonable business judgmentrequest for changes to the Second Development Program and consequential changes to the Development Budget or FTE commitment having been acceded to by the other Party) this shall be deemed notice of withdrawal from the Second Development Program by the Party refusing to ratify. Upon any such notice of withdrawal:
5.4.1 the provisions of Clauses 4.3 and 4.4 shall be deemed to apply such that the continuing Party shall have the fully paid up royalty free worldwide right to continue alone with development, commercialization, marketing, and sale of Candidate Product and any resulting Product; [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.4.2 the withdrawing Party shall upon the continuing Party's written request deliver up to execute the DEVELOPMENT PLAN continuing Party all Documents containing any Know How (save for a single copy to be retained for evidential purposes by the withdrawing Party's lawyers), and any other Know How, held by the withdrawing Party relating to carry out the activities Candidate Product and/or the resultant Product;
5.4.3 the withdrawing Party shall not use or otherwise exploit in any way, either directly or indirectly the Joint Program IP as it relates to the Candidate Product or any resulting Product in either case for FULL DEVELOPMENT all indications;
5.4.4 only the continuing Party shall be free to use and exploit all Joint Program IP as it relates to the Candidate Product or any resulting Product in either case for all indications as it sees fit with no obligation to the withdrawing Party in respect thereof provided however that both Parties shall be free to use and exploit all Joint Program IP, except as it relates to the Candidate Product or any resulting Product in either case for all indications, as each sees fit with no obligation to the withdrawing Party in respect thereof;
5.4.5 if the withdrawing Party is Columbia the licences granted by Columbia to Ardana pursuant to Clause 13.6 shall continue in full force and effect and shall be extended to the Columbia Territory and ROW and Columbia shall do all such acts and things as may be necessary to perfect this obligation and the provisions of the LICENSED PRODUCT so that JANS▇▇▇ ▇▇▇ launch the LICENSED PRODUCT Clauses 14.1, 14.3, 14.4, 14.6, and 14.7 shall continue to apply and shall be deemed expanded in the United States scope to place similar obligations on Columbia in relation to non-European Columbia IP owned by Columbia at Ardana's request and Europe no later than the 13 second quarter of the year 2000sole reasonable expense. In such circumstances Ardana shall assume sole responsibility for the course prosecution, maintenance, defence and enforcement of such efforts ILEX shallJoint Program IP at its own cost and expense, under the direction of JANS▇▇▇ ▇▇ coordinated by same terms, obligations, and consequences, and the PMT same standards for maintaining exclusive rights, as set forth in Article 3.1.2 heretoClause 4.3;
5.4.6 if the withdrawing Party is Ardana the licence granted by Ardana to Columbia pursuant to Clause 13.7 shall continue in full force and effect and shall be extended to the Ardana Territory and ROW and Ardana shall do all [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. such acts and things as may be necessary to perfect this obligation and the provisions of Clauses 14.3, take appropriate steps including 14.6, and 14.7 shall continue to apply. In such circumstances Columbia shall assume sole responsibility for the followingprosecution, maintenance, defence and enforcement of Joint Program IP at its own cost and expense, under the same terms, obligations, and consequences, and the same standards for maintaining exclusive rights, as set forth in Clause 4.4;
5.4.7 if the withdrawing Party is Columbia and it has obligations to manufacture and supply CTM and Finished Product under the terms of a Manufacturing and Supply Agreement entered into pursuant to Clause 9 these shall continue;
5.4.8 the withdrawing Party shall commensurate with legislative and regulatory requirements, transfer to the continuing Party or its nominee all Regulatory Approvals, Marketing Authorisations, Regulatory Applications and other regulatory filings and approvals for Candidate Product or resultant Product in all countries of the territory of the withdrawing Party and any country in the ROW Territory in relation to which the withdrawing Party has been appointed the Responsible Party pursuant to Clause 8. In the event that in any country such a transfer is not possible, the withdrawing Party shall use reasonable endeavours to ensure that the continuing Party has the benefit of the relevant Regulatory Approvals, Marketing Authorisations, Regulatory applications and other regulatory filings and approvals and, to this end, consents to any Governmental Authority cross-referencing to the data and information on file with any Governmental Authority as may be necessary to facilitate the granting of second Marketing Authorisations, applications, regulatory filings and approvals to the continuing Party, and the withdrawing Party agrees to complete whatever other procedures are reasonably necessary in relation to the same to enable the continuing Party (either itself or in conjunction with a third party) freely to develop and sell the Product in substitution for the withdrawing Party; and
5.4.9 the withdrawing Party shall use its reasonable endeavours to assign to the continuing Party the benefit of any agreement made between the [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. withdrawing Party, and a sub- licensee in relation to Product in ROW or any agreement between the withdrawing Party and an agent or distributor in any country to which Clause 8.1 relates.
5.5 In the event that during the course of the Development Program the DC identifies a strategic, legal, commercial, safety, efficacy, formulation, scientific or technical reason which means that both Parties wish to abandon the development of the Candidate Product, then this Agreement shall terminate by their mutual agreement to do so (such mutual agreement being said decision of the DC ratified by both the CEO of Ardana and the CEO of Columbia). Following any such termination Ardana shall not use or exploit in any way whatsoever the Columbia IP, and both Parties shall not use or exploit the Joint Program IP in relation to the Candidate Product or resultant Product in either case for any indication without the other Party's prior written consent.
5.6 In the event that the Second Development Program continues to its satisfactory conclusion and filings for Regulatory Approval are made in the Columbia Territory and filings for Marketing Authorisation are made in the Ardana Territory as specified in Clause 5.1 and subsequently such Regulatory Approvals and/or Marketing Authorisations are granted:
5.6.1 Columbia shall own and hold the Regulatory Approvals for the Columbia Territory and thereafter shall be solely responsible for ensuring that all Applicable Laws and other regulatory or other obligations arising as a result thereof or in relation thereto are met.
5.6.2 Ardana shall own and hold the Marketing Authorisations for the Ardana Territory and thereafter shall be solely responsible for ensuring that all Applicable Laws and other regulatory or other obligations arising as a result thereof or in relation thereto are met.
5.6.3 Columbia shall be solely responsible (as between Columbia and Ardana) at its own cost and expense for the Commercialisation of the Product in the Columbia Territory and shall have the exclusive benefit of all revenues generated in relation thereto. It is agreed that whilst the final decision on [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Packaging and Labelling shall be Columbia's, the Packaging and Labeling will be marked with all relevant patent numbers in each country of the Territory, as may be required by local patent law or practice or otherwise permitted under Applicable Law and the MAs.
5.6.4 Ardana shall be solely responsible (as between Ardana and Columbia) at its own cost and expense for the Commercialisation of the Product in the Ardana Territory and shall have the exclusive benefit of all revenues generated in relation thereto. It is agreed that whilst the final decision on Packaging and Labelling shall be Ardana's, the Packaging and Labeling will be marked with all relevant patent numbers in each country of the Territory, as may be required by local patent law or practice or otherwise permitted under Applicable Law and the MAs.
5.6.5 As and when any variation to any Regulatory Approval or Marketing Authorisation is made each Party shall supply a copy thereof to the other Party.
5.6.6 The Parties shall co-ordinate and liaise with each other in connection with Commercialisation of the Product in the Ardana Territory and Columbia Territory respectively and shall establish a separate committee for this purpose. In particular but not limiting the foregoing each party shall supply details of its Commercialisation Know How to the other. The Commercialisation Committee:
(ia) Establish and maintain a program reasonably designed, funded and resourced to complete PHASE III trials on the LICENSED PRODUCT for the LEAD INDICATIONshall be constituted as specified in Clause 2.1.1;
(ii) Proceed following successful completion of PHASE III trials, other associated studies and all other work which the PMT reasonably deems to be required, to prepare and compile the necessary regulatory documentation for inclusion in a filing of MARKETING AUTHORIZATION APPLICATIONS in the United States and Europe for the LICENSED PRODUCT for the LEAD INDICATION. In the case of Europe, the filing may be based on the EC multistate procedure or individual filings in at least the EUROPEAN MAJOR MARKET COUNTRIES.
(b) In carrying out shall be purely a co-ordination, liaison and communication forum and shall not be a decision making body (all decisions about Commercialisation being reserved exclusively to Ardana in respect of the DEVELOPMENT PLAN, ILEX Ardana Territory and Columbia in respect of the Columbia Territory);
(c) shall make available the number of qualified "full time equivalents" of its scientific, engineering, manufacturing and other personnel meet as specified in Clauses 2.2.1 and 2.1.3; and [***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) shall be a channel for communication between the DEVELOPMENT PLAN, Parties requesting amendments to this Agreement (if any such requests are made) so that Commercialisation by such Party can occur in the most tax efficient manner for such Party.
5.7 Each Party shall be responsible for acquiring any and all Trade Marks for Product(s) in their respective territory and shall take have sole responsibility for selection, clearance and registration of said Trade Marks in such steps as it deems necessaryterritory provided always that the Parties shall liaise with each other in relation thereto. The Parties agree that, in order to perform its obligations in accordance with for Trade Marks owned jointly by the terms hereof. ILEX shall use its best based Parties or owned by one Party and used by or on its reasonable business judgment efforts to carry out behalf of the DEVELOPMENT PLAN in accordance with other Party, the agreed upon time 14 and event schedule, in consultation with Party using the PMT. JANS▇▇▇▇ shall have will ensure that the right to control manner, form, and direct performance quality of all use of such Trade Marks will be at the approval of at least one Party owner of the DEVELOPMENT PLAN through the PMTMarks, and shall have the right to approve any material agreement with third parties to be made by ILEX related to performance of the DEVELOPMENT PLAN hereunder which approval shall not be unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS 5.8 If at any time following First Commercial Sale by Columbia in the Columbia Territory or by Ardana in the Ardana Territory either of them should decide to withdraw the Product from such territory on a permanent basis for whatever reason they shall give 90 days written notice of the same to the other Party and this shall be compiled deemed a notice of withdrawal under Clause 5.4 and if the other Party so wishes it shall have the exclusive 90 day right to run from the date of receipt of such written notice and exercisable by ILEX based notice in writing to the withdrawing Party to take over such territory on information generated during the FULL DEVELOPMENT program. At JANS▇▇▇'▇ ▇▇▇ion, MARKETING AUTHORIZATION APPLICATIONS shall either be filed by JANS▇▇▇ ▇▇ filed by ILEX and transferred terms of Clauses 5.4.1 to JANS▇▇▇. JANS▇▇▇ ▇▇▇ll own all such MARKETING AUTHORIZATIONS. JANS▇▇▇ ▇▇▇ll exercise reasonable efforts, commensurate with the efforts it would normally exercise for products of similar potential sales volume and consistent with its overall business strategy to obtain MARKETING AUTHORIZATION for LICENSED PRODUCT in such countries as JANS▇▇▇ ▇▇▇ms appropriate. JANS▇▇▇ ▇▇▇ll prosecute such submissions and file the necessary reports and responses to requests fromt he pertinent regulatory authorities. ILEX shall prepare supporting documentation requested by JANS▇▇▇. ▇LEX shall further assist JANS▇▇▇ ▇▇▇h the preparation of supporting data to apply for and pursue MARKETING AUTHORIZATION APPLICATIONS.5.4.9
Appears in 1 contract
Sources: Development and License Agreement (Columbia Laboratories Inc)