Common use of Development Program Clause in Contracts

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) to conduct a development program (the “Development Program”) relating to the use of the Licensed Product for HBV and (b) if the results of the Development Program so justify, to seek Registration for such Licensed Product in the United States. As part of the Development 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. 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 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 out-of-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant to Article 7 and shall take into 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 this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED].

Development Program. Subject to Bukwang’s 's timely performance of its obligations hereunder, and in complete fulfillment of Triangle’s '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 [BUKWANG REDACTED] *** (a) to conduct a development program (the “"Development Program”") relating to the use of the Licensed Product for HBV and (b) if the results of the Development Program so justify, to seek Registration for such Licensed Product in the United States. As part of the Development 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. 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 Bukwang shall promptly reimburse Triangle for [BUKWANG REDACTED] *** of the 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 out-of-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant to Article 7 and shall take into 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 's sole discretion. Anything in this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] *** obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]*** .

Development Program. Subject to Bukwang’s timely performance of its obligations hereunderThe initial Development Program set forth in Exhibit C was prepared by BDSI, and in complete fulfillment shall be subject to review by and comments from Meda, as approved by the Development Committee within *** 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 the HSR Date. BDSI shall use Commercially Reasonable Efforts to undertake, the conduct pre-Governmental Approval Licensed Product development activities described in accordance with the Development 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). Notwithstanding the foregoing or any other provision of this Article 6. Triangle shallAgreement, at its expense, use its [BUKWANG REDACTED] Meda acknowledges and agrees that (a) to conduct a development program (the “Development Program”) relating to the use of the Licensed Product for HBV 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 opportunity to review and comment (which opportunity shall not be 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 results 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 include BDSI in such efforts in a consultative capacity. 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 so justify, to seek Registration for include such Licensed Product above-described development shall not limit Meda’s obligations in the United States. As part of the Development 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. 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 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 out-of-pocket costs. The Development Program shall be mutually discussed by the parties hereto at the meetings of the Joint Project Committee held pursuant to Article 7 and shall take into 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 this Agreement to the contrary notwithstanding, Triangle shall be entitled to exercise prudent and justifiable business judgment in meeting its [BUKWANG REDACTED] obligations hereunder. For purposes of this Article 6, [BUKWANG REDACTED]preceding sentence.