Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.
Commercial Supply After the Option Termination Date: (a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.
Development Efforts 4.2.1 Hana shall use Commercially Reasonable Efforts to Develop each Product in the Territory (including carrying out its responsibilities under the Development Plan) to: (a) conduct or cause to be conducted the necessary and appropriate clinical trials as necessary to obtain and maintain Regulatory Approvals for each Product; and (b) prepare, file and prosecute or cause to be prepared, filed and prosecuted the Regulatory Submission for each Product. 4.2.2 Hana will provide INEX with written reports to keep INEX fully informed of the progress of the Development of each Product as follows: (a) at the close of each Calendar Quarter during the first twenty-four (24) months following the Effective Date of the Definitive Agreements; and (b) on or before June 31 and December 31 of each and every calendar year thereafter.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Commercial Diligence (a) Licensee shall use Commercially Reasonable Efforts to Commercialize Product in the Field in each country or jurisdiction in the Licensed Territory in which it receives Regulatory Approval. After the launch of each Product in the Field in the Licensed Territory, Licensee shall commit at least the same number of sales representatives and the same level of resources and infrastructure in connection with the Commercialization of such Product as are expended by Licensee and similarly-sized pharmaceutical companies with similarly-sized infrastructure to support and carry out similar operations in connection with the commercialization of products with similar market potential. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the Exchange Act of 1934, as amended. Confidential Portions are marked: [***] (b) Licensee shall achieve First Commercial Sale of (i) the Surfaxin Product and/or Surfaxin LS, as the case may be, [***] after Drug Approval therefor has been obtained from the appropriate Regulatory Authority (or pricing and reimbursement approval where applicable) [***] to Commercialize the Surfaxin Product and Surfaxin LS, as applicable, [***]; and (ii) Aerosurf [***] after the appropriate Regulatory Authority [***] has approved Licensor’s imported product registration permitting Licensee to Commercialize Aerosurf [***], provided that Aerosurf is made available [***] by Licensor within a reasonable period of time in advance of the deadlines set forth in this Section 6.6(b). (c) Licensee’s FTE and marketing spend (inclusive of costs of sales force, marketing materials, trade show attendance and medical affairs team) in respect of Commercializing the Surfaxin Product, Surfaxin LS and Aerosurf in the Licensed Territory shall be not less than [***] of the gross forecasted revenues expected to be derived from the sale of such Products as set forth in the Commercialization Plan.