Product Development. (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information.
(b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** 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. instance, each party’s decision whether to participate will be ma...
Product Development. 3.1 Radius shall, at its own expense, carry out all necessary pre-clinical and clinical studies related to Compound and/or Product required by the relevant authorities throughout the Territory to achieve Product registration for the Product in those countries within the Territory for which Radius believes it should obtain registrations for Product in at least the United States, the United Kingdom, France, Germany, Italy and Spain. Radius shall use all its commercially reasonable efforts in developing Compound and/or Product in the Territory in accordance with its normal practices and procedures for pharmaceutical compounds having similar technical and commercial potential (taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved and profitability) and for which it has similar rights.
3.2 Radius shall use all its commercially reasonable efforts to obtain regulatory approvals for Product in the Territory as required for the manufacture, importation, marketing, promotion, pricing and sale of the Product(s) in those countries in the Territory where Radius seeks to market and sell Products. Attainment and maintenance of regulatory approvals for Product in the * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. Territory shall be carried out by Radius. Radius shall bear all other expenses which it incurs in the attainment and maintenance of regulatory approvals and price registration activities in the Territory. Radius shall keep Eisai fully apprised of the status of regulatory approvals and price registrations in the Territory when it files for such approvals and when it receives such approvals.
3.3 The Parties intend and agree that the Development and commercialization of Products in the Territory shall be Radius’s responsibility and that Radius shall have full responsibility for, and control of, pre-clinical and clinical development and commercialization of Products in the Territory, including the authority to make all decisions, and undertake any actions necessary as a result of such decisions, regarding preclinical and clinical development plans and filing INDs and BLAs. Notwithstanding the foregoing, Radius shall provide Eisai the opportunity to provide input and suggestions into matters relating to the Development of Products, and Radius shall not unreasonably refuse to consider...
Product Development. Attach all requested documentation and attach additional pages as necessary. For all requirements include efforts of all Sublicensees. If not applicable, please so indicate by N/A.
A. Provide the commercial name of any FDA-approved products, incorporating, using or that are Licensed Products/Licensed Methods that have first reached the market during the designated reporting Period. (This information is necessary for federal funding reporting requirements) Licensed Product (Name): Estimated Date of First Sale: FDA approval stage Contact Person Estimated Start Time Estimated End Time Estimated Budget Preclinical NDA Phase I Phase II Phase III Animal Studies Mfg./Production Facility Licensed Product (Name): Estimated Date of First Sale: Class Type: Completion Type: FDA Approval Stage Estimated Start Time Estimated End Time Estimated Budget PMA 501(k) IDE HDE Preclinical Phase I Phase II Phase III Mfg./Production Facility Licensed Product (Name): Estimated Date of First Sale: Contact Person Estimated Start Time Estimated End Time Estimated Budget Alpha Version Beta Version Commercial Version
Product Development. SB shall have responsibility for, and control of, the development and commercialization of each Product arising from this Agreement, including process development, delivery system and formulation development, preclinical studies, clinical studies, sales and marketing.
Product Development. Except as otherwise expressly provided in Articles 2 and 3 hereof and in this Article 4, Wyeth shall have the sole authority, at its expense, for the Development of Licensed Products, including the initiation and conduct of clinical trials. Wyeth shall be responsible for the Development of and shall use its Commercially Reasonable Efforts to Develop Licensed Products throughout the Territory where it is Commercially Reasonable to do so (it being understood that Wyeth shall have the sole discretion to select those countries in which it will conduct clinical studies of Licensed Products and, when Commercially Reasonable to do so, to delay or discontinue the Development of any Licensed Product directed against a particular Licensed Target in favor of pursuing Development of another Licensed Product directed against such Licensed Target). When appropriate based on the data obtained during Development, Wyeth shall use its Commercially Reasonable Efforts to secure Regulatory Approval for Licensed Products in the Territory.
Product Development. Work with tourism partners to undertake research, surveys and data analysis. Collaborate with tourism partners to undertake product or asset inventories; develop itineraries; improve the market-readiness of existing tourism experiences; undertake market-match studies; showcase local distinctiveness; create/develop new niche tourism products to entice and target new visitors (e.g., gardens, culinary, golf, biking, etc.); create tour routes; implement signage; and/or enhance programming and interpretation of experiences. Adapt programs into other languages or accessible formats. Establish annual targets for each product development strategy, so that the results can be compared to the desired or expected return.
Product Development. All Royalty Bearing Products shall be developed, manufactured, marketed, and sold as "premium" products consistent with MFB's then existing image. Nonni's accepts full responsibility for and agrees to pay all costs it incurs associated with the development of all Royalty Bearing Products and all advertising and promotion, packaging design, graphics, and packaging materials for Royalty Bearing Products. MFB shall cooperate with Nonni's in development of Royalty Bearing Products, primarily through the suggestion of ideas, concepts, and recipes for products and packaging (MFB shall make its artwork, designs and logos available for Nonni's use); provided, however, that MFB shall have no obligation to develop Royalty Bearing Products or any other products.
Product Development. Except as otherwise provided in this Agreement, including but not limited to in the provisions of Exhibits F and G hereto, product development and manufacturing for the Products will be performed by Riverstone. In the event that Tellabs proposes new versions of line cards for the Products that Riverstone declines to develop, Tellabs will have the right [ * ]. Riverstone agrees that modifications requested by Tellabs may require software modifications, both in line card and in non- line card software. Riverstone will have the first right to perform the development of new Product line cards that are [ * ]. Tellabs will have the right to develop new line cards for installation into the Products, other than a [ * ], that are substantially based upon [ * ]. The parties will follow the procedures set forth in Exhibit G and will develop mutually agreed procedures that ensure that developments by Tellabs are adequately tested and integrated into the Products.
Product Development. The following obligations shall be in effect during the Initial Term of this Agreement only:
Product Development. 4.1 Novo Nordisk shall, at its own cost and discretion, develop and obtain Regulatory Approval for the Licensed Product(s).
(a) Subject to the limitations provided in the definition of Program Carriers and Section 2.2(g) above, the Parties shall jointly select the Program Carriers for use in Licensed Products which are to be provided to, and screened by, Novo Nordisk. Emisphere shall use Commercially Reasonable Efforts to provide documentation specified by Novo Nordisk concerning the Program Carriers. The Parties agree that the Know-How related to the Program Carriers provided to Novo Nordisk, including structures of such Program Carriers and their availability as Exclusive Program Carriers at the time, must be disclosed by Emisphere to Novo Nordisk. Any Know-How related to Program Carriers provided to Novo Nordisk prior to the Effective Date shall be provided to Novo Nordisk promptly following execution of the Agreement, if any such Know-How has not already been provided. For the avoidance of doubt, once a specific Carrier has been jointly selected as a Program Carrier, Emisphere may not enter such Carrier on the Excluded Carrier List.
(b) Upon selection of a Carrier to be a Program Carrier in accordance with Section 4.2 (a), Know-How related to such Program Carrier shall become Licensed Know-How as of the Selection Date. Emisphere shall continue to provide Licensed Know-How to Program Carriers to Novo Nordisk throughout the Term.
(c) If requested by Novo Nordisk, representatives of Emisphere shall participate, at Novo Nordisk’s cost, in a technology transfer session(s) of commercially reasonable scope and length to be held in Denmark or in the US as decided by Novo Nordisk at its sole discretion.
4.3 Novo Nordisk shall be solely responsible for the development, development plan(s), and commercialization for the Licensed Product(s) and for all of the costs of the development and commercialization of the Licensed Product(s). Novo Nordisk shall own all clinical data and other results, without limitation, arising out of the work under this Agreement and shall continue to own all data and results which were generated under the Option Agreement from the carrying out of the Work Plan (as defined in the Option Agreement) and reports describing such data and results. Novo Nordisk shall not, directly or indirectly, attempt to chemically modify, or create derivative materials from any Program Carriers.
4.4 Emisphere shall use Commercially Reasonable Efforts to perf...
