Development of Products. (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.
Development of Products. 37 4.1 Responsibilities of the Parties .......................................... 37 4.2
Development of Products. 28 3.5. Laboratory Facilities and Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Development of Products. 4.1 During the Research Term, Orasense will diligently pursue the research and development of the Elan Intellectual Property, Isis Intellectual Property and Orasense Technology in accordance with the Research and Development Program. The objectives of this initial phase of the Research and Development Program will be (a) to develop the Oral Platform, and (b) to develop the Development Product.
4.2 The results of Orasense's research pursuant to the Research and Development Program shall be shared with Isis and, in the event Isis utilizes such data in connection with a product based upon the Development Candidate in a non-Oral formulation and includes such data in any regulatory submission and the use of such data substantially enhances such application, and a product which is the subject of such application is Commercialized, Isis agrees to negotiate in good faith reasonable compensation to Orasense for the use of such data.
4.3 Isis agrees to provide at Orasense's cost such amounts of the Isis Oligonucleotide Drugs designated by Isis as [...***...] and [...***...] as Orasense shall require for testing and research purposes only; provided however, that no clinical studies on humans may be performed utilizing [...***...].
4.4 Orasense will diligently pursue the research, development and Commercialization of the Development Product and other Products in accordance with the Plan, this Agreement, the Elan License Agreement and the Development Agreement.
4.5 In the event the Management Committee, by unanimous vote of its members, shall determine that preclinical toxicology or pharmacology studies indicate that clinical trials of the Development Candidate should not be undertaken, or the Management Committee determines that development of the Development Candidate is not economically viable, Isis in good faith shall offer, and the Management Committee, by unanimous vote of its members shall approve, an Isis Oligonucleotide in pre-clinical development that it deems economically viable as a Substituted Development Candidate, subject to the agreement of the Participants, negotiating in good faith, to changes concerning the budget, Plan and funding of Orasense.
4.6 Except as otherwise provided herein, upon designation of an Isis Oligonucleotide as a Substituted Development Candidate, (i) all rights to the Development Candidate shall revert to Isis and (ii) all provisions contained herein other than in the preceding clause (i) relating to the Development Candidate sha...
Development of Products. Lilly will in its discretion determine which, if any, such Hit(s), or Derivative(s) of Hit(s), will be approved as an Approved PTAC Compound. Lilly will be responsible for all pre-clinical and clinical development, including all regulatory filings, of Hits and Approved PTAC Compounds arising out of this Agreement. Lilly shall have discretion and control over the conduct of, and all activities associated with, the development or abandonment of any Approved *** CONFIDENTIAL TREATMENT REQUESTED
Development of Products. BMS will in its sole and absolute discretion determine which, if any, such Hit(s) will be approved as Lead Compounds and developed further in a Lead Compound Development Program conducted by BMS. BMS shall be responsible for all pre-clinical (including medicinal chemistry) activities during the course of the Lead Compound Development Program for such Lead Compound, as well as following any approval of an Approved PLP Compound. The conduct of the Lead Compound Development Program shall be solely within the control and discretion of BMS, and BMS may in its discretion suspend or terminate, in whole or in part, the Lead Compound Development Program for a Lead Compound at any time. BMS will be responsible for all pre-clinical and clinical development, including all regulatory filings, of Hits, Lead Compounds, and Approved PLP Compounds arising out of this Agreement. BMS shall have sole and absolute discretion and control over the conduct of, and all activities associated with, the development or abandonment of any Hit or Lead Compound, the approval of a Lead Compound as an Approved PLP Compound, the development or abandonment of any Approved PLP Compound, all regulatory activities relating to the manufacture, use or sale of any Approved PLP Compound or Product, and the commercialization and marketing of any Product in any country. All INDs, NDAs and other regulatory filings made or filed by BMS for any Approved PLP Compound or Product shall be owned solely by BMS. BMS will provide summary annual reports to Aurora on the development status of any Approved PLP Compound then in development arising out of the ESP Screening Program and which shall *** CONFIDENTIAL TREATMENT REQUESTED 35 39 be treated as BMS Confidential Information hereunder. Other than royalty reports required hereunder, no reports shall be required of BMS with respect to any activities connected with the commercialization of any Product approved for marketing in any country.
Development of Products. Senomyx will be responsible, at Senomyx's expense, for all formulation and regulatory approval of Products arising out of this Agreement. Senomyx shall use reasonable efforts, consistent with commercial business practices, to develop any Product, to perform all regulatory activities relating to the manufacture, use or sale of any Product, and to commercialize and market any Product in any country. All regulatory filings made or filed by Senomyx for any Development Compound or Product shall be owned solely by Senomyx. At Senomyx's request and expense, Aurora shall cooperate to the extent reasonably necessary to permit Senomyx to perform the foregoing activities.
Development of Products. Unless and until an Optionee or a Third Party effects the closing of a transaction hereunder with respect to a Licensed Product, the Company (and/or Local Operating Entities) shall have the sole right to Develop such Licensed Product in the Fields in the Territory and shall use Commercially Reasonable Efforts to undertake all Development activities with respect to such Licensed Product in the Fields pursuant to the Initial Business Plan, the Initial Budget, the Rolling Business Plan and the Rolling Budget. For clarity, the Company (and/or Local Operating Entities) shall be the lead regulatory party with respect to such Licensed Product in the Fields in the Territory prior to the Opt-In Effective Date with respect to such Licensed Product, and the Company (and/or Local Operating Entities) shall submit and own all Regulatory Approvals and Registration Filings with respect to the Development of Licensed Products in the Fields in the Territory.
Development of Products. GEMINI shall be responsible for all activities and costs associated with the further research, development, manufacture, marketing and commercialisation of PRODUCTS utilising the ELAN TECHNOLOGY.
Development of Products. Spectral shall, at its sole cost and expense, use commercially reasonable efforts to develop and commercialize the Products, in the area of medical applications and such other areas, if any, as Spectral in its sole discretion shall determine. Spectral shall provide a written report to the Inventors every year during the Term, stating in reasonable detail all significant progress achieved and material difficulties encountered since the last such report in the development of Products. The parties acknowledge that (i) the Endoscopic Invention and the CMU Technology are at an early stage of development and are not yet ready for clinical development, and (ii) Spectral will need to raise significant capital before it can carry out substantial development activities with respect to the Endoscopic Invention and the CMU Technology. CDI and the Inventors acknowledge that Spectral intends to own, acquire and develop other technologies in the spectral or molecular imaging field having medical or other applications and that these technologies shall not be subject to the terms of this Agreement.
