Common use of Development Effort Clause in Contracts

Development Effort. NOVACEA agrees at its sole cost and expense to use its best efforts to obtain Approval to market Finished Product in such countries in the Territory as shall be reasonably determined by NOVACEA, except that NOVACEA shall use its best efforts to obtain FDA Approval to market Finished Product in the United States based upon a NDA or ANDA, as shall be determined by NOVACEA. Notwithstanding the foregoing, if NOVACEA enters into an agreement with an effective date of no later than [*] with a Commercialization Partner to commercialize the Finished Product, then the standard above shall not apply and instead the standard provided in NOVACEA’s agreement with such Commercialization Partner shall apply which will at least be a commercially reasonable efforts standard. Alternatively, if this Agreement is assigned to such Commercialization Partner, then the standard applicable to the Commercialization Partner shall be the commercially reasonable efforts standard. In connection with the FDA Approval described above, NOVACEA shall at its sole cost and expense conduct all tests and studies reasonably required to enable NOVACEA to apply for, obtain and maintain FDA Approval for Finished Product. In connection with the development of Finished Product and securing any Approvals, NOVACEA agrees, on behalf of itself, its Affiliates and their respective licensees or contract manufacturing vendors, if any, to use only API obtained from PLANTEX (or its Affiliates) and from the second source that NOVACEA proposes to utilize pursuant to Section 5.1 below, and purchase all their respective development requirements of API from PLANTEX (or its Affiliates) and such second source. Upon the execution and delivery of this Agreement, PLANTEX shall provide and deliver to NOVACEA without charge two (2) grams of API. Thereafter, NOVACEA shall be charged [*] dollars ($[*]) per gram for Developmental Orders (as herein defined) of API sold hereunder and such price shall not be subject to increase or decrease. Notwithstanding Section 6.2 below, such payment shall be due and payable upon delivery to NOVACEA of any Developmental Order or portion thereof. As used herein, “

Development Effort. NOVACEA D-NOVO agrees at its sole cost and expense to use its best efforts to obtain Approval to market Finished Product in such countries in the Territory as shall be reasonably determined by NOVACEAD-NOVO, except that NOVACEA D-NOVO shall use its best efforts to obtain FDA Approval to market Finished Product in the United States based upon a NDA or ANDA, as shall be determined by NOVACEA. Notwithstanding the foregoing, if NOVACEA enters into an agreement with an effective date of no later than [*] with a Commercialization Partner to commercialize the Finished Product, then the standard above shall not apply and instead the standard provided in NOVACEA’s agreement with such Commercialization Partner shall apply which will at least be a commercially reasonable efforts standard. Alternatively, if this Agreement is assigned to such Commercialization Partner, then the standard applicable to the Commercialization Partner shall be the commercially reasonable efforts standardD-NOVO. In connection with the such FDA Approval described aboveApproval, NOVACEA D-NOVO shall at its sole cost and expense conduct all tests and studies reasonably required to enable NOVACEA D-NOVO to apply for, obtain and maintain FDA Approval for Finished Product. In connection with the development of Finished Product and securing any Approvals, NOVACEA D-NOVO agrees, on behalf of itself, its Affiliates and their respective licensees or contract manufacturing vendors, if any, to use only API obtained from PLANTEX (or its Affiliates) and from the second source that NOVACEA proposes to utilize pursuant to Section 5.1 below, and purchase all of their respective development requirements of API from PLANTEX (or its Affiliates) and such second source). Upon the execution and delivery of this Agreement, PLANTEX shall provide and deliver to NOVACEA D-NOVO without charge two grams (22 gms.) grams of API. Thereafter, NOVACEA D-NOVO shall be charged [*] dollars ($[*]) per gram for Developmental Orders (as herein defined) of API sold hereunder and such price shall not be subject to increase or decrease. Notwithstanding Section 6.2 below, such payment shall be due and payable upon delivery to NOVACEA of any Developmental Order or portion thereof. As used herein, “Developmental Orders” means orders placed prior to Approval by a Regulatory [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Authority and not in connection with commercial production in connection with commercial launch following any such Approval. All Developmental Orders shall be minimum noncancellable orders for quantities of not less than [*] grams each. Each of the Developmental Orders shall be deliverable over periods not exceeding twelve (12) months, in partial shipments of not less than [*] grams each.