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 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.

Development Effort. NOVACEA agrees at its sole cost (a) During the term of this Agreement, Licensee will undertake to initiate within ten (10) months of the effective date of this Agreement, laboratory 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 controlled clinical studies in the United States based upon a NDA or ANDAof the Licensed Products. If Licensee does not begin clinical studies within that time, 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 technology and patent rights will revert 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 Licensor pursuant to Section 5.1 below6.4, except in the event that any regulatory agencies do not permit the commencement of such clinical trials. In such event, this time requirement shall be tolled until such time as such regulatory agencies permit such clinical investigation with such Licensed Product. Reversion to Licensor pursuant to this Section shall occur only after Licensor gives Licensee thirty (30) days prior written notice to this effect in accordance with this Agreement, after which Licensee will have ninety (90) days to cure the relevant omission and purchase all their respective development requirements of API from PLANTEX retain rights to the invention. (or its Affiliatesb) and such second source. Upon the execution and delivery Licensees determination to undertake such clinical studies, during the term of this Agreement, PLANTEX Licensee will exercise, at its expense, its reasonable efforts and diligence consistent with sound business and medical judgment of Licensee in developing and commercializing Licensed Products, and in undertaking at its expense, all investigations and actions required to obtain appropriate governmental approvals as deemed necessary to market Licensed Products. At Licensee's expense, Licensor will cooperate in conducting studies along with others to support Licensed Products which are reasonable in scope for Licensor to conduct and Licensor will supply to Licensee reasonable technical assistance in undertaking such investigations and actions. (c) If Licensee elects to pursue the commercialization of Licensed Product beyond the studies set forth above, Licensee shall provide seek marketing approval from the United States FDA including if necessary, the filing of a New Drug Application ("NDA") with the United States Food and deliver Drug Administration prior to NOVACEA without charge January 31, 2002. If Licensee does not file a NDA within that time and thereafter, diligently seek Approval consistent with the sound business and medical judgment of Licensee, the Patents and Know-how will revert to Licensor pursuant to Section 6.4, provided, however, that at the sole option of Licensee, Licensee may extend this time period by two (2) grams years by paying the Licensor an extension fee of API$250,000. ThereafterReversion to Licensor pursuant to this provision shall occur only after Licensor gives Licensee thirty (30) days prior written notice to this effect in accordance with this Agreement, NOVACEA shall be charged [*] dollars after which Licensee will have ninety ($[*]90) per gram for Developmental Orders (as herein defined) of API sold hereunder days to cure the relevant omission and such price shall not be subject retain licensed rights 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, “the invention.