Common use of Development Programme Clause in Contracts

Development Programme. 2.1 Abbott hereby agrees to undertake the Development Programme as outli▇▇▇ ▇▇ Schedule A hereto, including, without limitation, manufacturing Bulk Product and Finished Product in accordance with the Specifications which shall be agreed to by the parties. On payment by Barrier of the irrevocable sum of US$ [**] prior to commencement of Stage 2 of the Development Programme, Abbott undertakes to ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. develop Meltrex(TM) formulations of Drug Substance exclusively for Barrier. Barrier represents and warrants that it shall not sell any Bulk Product or Finished Product manufactured by Abbott for use in the Development Programme to any third party ▇▇▇ ▇hall only use such Bulk Product and Finished Product in preapproval clinical and in vitro studies until the supply agreement referred to in Article V is signed by both parties. Schedule B shall consist of a number of Workplans which may be added to or amended from time-to-time by mutual agreement of the parties. The aim of such Development Programme is to enable Abbott to perform all the development and scaling-up activitie▇ ▇▇▇▇ired (i) to provide sufficient samples of Finished Product for Barrier to carry out further testing in humans; and (ii) to provide batches of Bulk Product and Finished Product for validation and other requirements of Regulatory Agencies; and (iii) to generate such data and documentation related to the manufacture of Bulk Product and Finished Product as are necessary to enable Barrier to apply to Regulatory Agencies for marketing authorisation for Finished Product. 2.2 Abbott shall use all reasonable efforts to carry out and complete ea▇▇ Workplan within the agreed timetable. Both parties undertake to keep each other informed of any possible or anticipated change in their respective timescales of activities which may affect the Development Programme. 2.3 If at any time during the Development Programme, Abbott anticipates that for any reason whatsoever it is no lon▇▇▇ ▇▇ a position to complete any part of the ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. Development Programme within the timetables provided for in Schedules A and B, it will promptly so notify Barrier and both parties will immediately review the situation and seek to agree any revisions to the Development Programme.

Development Programme. 2.1 Abbott hereby agrees 7.1 Subject to undertake ARROW'S timely performance of its obligations hereunder, and in complete fulfilment of TRIANGLE'S development obligations hereunder and any such obligations implied by law, TRIANGLE will undertake, or will cause its AFFILIATES or SUB-LICENSEES to undertake, the Development Programme as outli▇▇▇ ▇▇ Schedule A heretodevelopment activities described in this Article 7. TRIANGLE shall, including*** , without limitation, manufacturing Bulk Product use its best efforts to conduct a development program (the "DEVELOPMENT PROGRAMME") in the U.S. relating to the use of at least one PRODUCT containing a given ARROW SELECTED COMPOUND and Finished Product to seek REGISTRATION for such PRODUCT in accordance with the Specifications which at least one MAJOR MARKET COUNTRY. The DEVELOPMENT PROGRAMME shall be agreed to mutually discussed by the partiesparties hereto and shall take into consideration studies and experiments carried out, or to be carried out by, ARROW, but the activities comprising the DEVELOPMENT PROGRAMME shall be determined at TRIANGLE'S sole discretion. On payment Anything in this AGREEMENT to the contrary notwithstanding, TRIANGLE shall be entitled to exercise prudent and justifiable business judgement in meeting its best efforts obligations hereunder. For purposes of this Article 7, "best efforts" shall mean that TRIANGLE shall use reasonable efforts consistent with those used by Barrier of the irrevocable sum of US$ [it in its development projects with other compounds in its development portfolio deemed to have comparable commercial potential. ---------- **] prior to commencement * Portions of Stage 2 of the Development Programme, Abbott undertakes to ** Certain information in this exhibit has page have been omitted pursuant to a request for Confidential Treatment and will be filed separately with the Securities Commission. 7.2 Subject to the foregoing provisions of this Article 7, TRIANGLE'S best efforts obligations set forth in this Article 7 shall be deemed to have been satisfied if TRIANGLE: (a) files an IND in a MAJOR MARKET COUNTRY for the first PRODUCT containing a given ARROW SELECTED COMPOUND within *** months after the date on which such ARROW SELECTED COMPOUND has been selected as a candidate for the DEVELOPMENT PROGRAMME by the JOINT STEERING COMMITTEE. (b) files in at least one MAJOR MARKET COUNTRY what it reasonably believes to be a complete NDA for such PRODUCT with the appropriate regulatory agency within *** months after the ARROW SELECTED COMPOUND contained in such PRODUCT is selected for the DEVELOPMENT PROGRAMME by the JOINT STEERING COMMITTEE. The time periods set forth in clauses (a) and Exchange Commission (b) shall each be subject to up to *** extensions of *** each at TRIANGLE'S election by payment to ARROW of a sum of *** Dollars ($ *** ) for each such *** extension. (a) In the event TRIANGLE fails to meet any diligence requirements set forth in Section 7.2(a) or 7.2(b) with respect to a given PRODUCT, and does not demonstrate to ARROW's reasonable satisfaction that, despite TRIANGLE'S efforts, the failure to meet the diligence requirements was delayed due to reasons beyond TRIANGLE'S reasonable control, ARROW shall have the option, at its sole and exclusive remedy, to terminate the AGREEMENT in the entire TERRITORY with respect only to such PRODUCT. (b) Prior to exercising any rights under this Section 7.3, ARROW shall give ---------- *** Portions of this page have been omitted pursuant to a confidential treatment request. develop Meltrex(TM) formulations of Drug Substance exclusively request for Barrier. Barrier represents Confidential Treatment and warrants that it shall not sell any Bulk Product or Finished Product manufactured by Abbott for use in the Development Programme to any third party ▇▇▇ ▇hall only use such Bulk Product and Finished Product in preapproval clinical and in vitro studies until the supply agreement referred to in Article V is signed by both parties. Schedule B shall consist of a number of Workplans which may be added to or amended from time-to-time by mutual agreement of the parties. The aim of such Development Programme is to enable Abbott to perform all the development and scaling-up activitie▇ ▇▇▇▇ired (i) to provide sufficient samples of Finished Product for Barrier to carry out further testing in humans; and (ii) to provide batches of Bulk Product and Finished Product for validation and other requirements of Regulatory Agencies; and (iii) to generate such data and documentation related to the manufacture of Bulk Product and Finished Product as are necessary to enable Barrier to apply to Regulatory Agencies for marketing authorisation for Finished Product. 2.2 Abbott shall use all reasonable efforts to carry out and complete ea▇▇ Workplan within the agreed timetable. Both parties undertake to keep each other informed of any possible or anticipated change in their respective timescales of activities which may affect the Development Programme. 2.3 If at any time during the Development Programme, Abbott anticipates that for any reason whatsoever it is no lon▇▇▇ ▇▇ a position to complete any part of the ** Certain information in this exhibit has been omitted and will be filed separately with the Securities Commission. TRIANGLE *** notice and Exchange Commission shall meet with TRIANGLE in London, at TRIANGLE'S request, during such *** period, to discuss any disagreements about whether TRIANGLE has complied with the applicable diligence requirements of this Article 7. Upon expiration of such *** period, ARROW shall have the right in its sole discretion to proceed with the exercise of all rights and remedies provided for herein unless the applicable diligence requirement is fulfilled during such *** period. (c) Upon termination by ARROW of this AGREEMENT pursuant to a confidential treatment request. Development Programme within this Section 7.3, the timetables provided for provisions of Article 14.2 shall apply in Schedules A and B, it will promptly so notify Barrier and both parties will immediately review the situation and seek to agree any revisions to the Development Programmerespect of such PRODUCT.