Cellegy Obligations Clause Samples

Cellegy Obligations. Promptly following entering into this Agreement Cellegy shall: (a) provide Licensee with a complete copy of the Cellegy Information as well as copies of clinical data, analysis and reports of Cellegy or its other licensees of the Licensed Product in other countries (to the extent in Cellegy’s possession and that Cellegy is permitted to provide such information under the terms of its agreements with such licensees, with Cellegy agreeing to use commercially reasonable efforts after the date of this Agreement to include provisions in agreements with other licensees of the Licensed Product to permit the sharing of such data, analysis and reports from licensees); (b) provide Licensee with any information in its possession that is reasonably likely to jeopardize or otherwise have a material adverse impact on the application, or any grant, maintenance, variation or renewal of the Approvals; (c) except as provided in Section 5.8 above, at its cost promptly provide to Licensee a sufficient quantity of the Licensed Product as is reasonably necessary for Licensee to prepare and submit the application, and the grant, maintenance, variation or renewal of Approvals; (d) use Commercially Reasonable and Diligent Efforts to assist Licensee and to procure the assistance of any third party supplier of raw materials to Cellegy, in meeting the demands of the Relevant Regulatory Authority relating to any application and any grant, maintenance, variation or renewal of Approvals; (e) deliver to Licensee the Technical Agreement that Cellegy has entered into with the Manufacturer; and (f) notify Licensee and promptly provide all relevant assistance and supporting documentation to Licensee, should Cellegy make any alteration to the Licensed Product, or the manufacture, or packing of the Licensed Product that needs to be notified to a Relevant Regulatory Authority.

Cellegy Obligations. (a) During the Term of this Agreement, Cellegy shall: (i) manage regulatory review and compliance, order fulfillment, manufacturing and clinical development of the Product and all related matters; (ii) develop and assemble an adequate distribution chain and utilize reasonable efforts to ensure the provision of a sufficient supply of commercial Product stock as may be required for the distribution chain and end-user demand; (iii) utilize reasonable efforts to provide a sufficient supply of Product Samples for the Product Detail Team such that, on an annual basis, at least ** percent (**%) of targeted physicians are provided with Product Samples; (iv) to the extent Cellegy pursues any additional indications for the Product, provide all clinical support for any such additional indications promoted by Ventiv; (v) oversee and administer compliance by the Product manufacturer with applicable regulatory and administrative cost guidelines, including the utilization of reasonable efforts to ensure Manufacturing Costs do not exceed ** percent (**%) of Product Revenues; (vi) assess and resolve all trade and wholesale issues involving inventory or distribution of the Product; (vii) hire a co-Product manager reasonably acceptable to Ventiv; (viii) seek in good faith to maximize Product Revenues and Contribution Margins, and minimize the effect of price promotions and/or rebates; (ix) produce all collateral materials and samples for the Product Detail Team, and pay all costs and expenses associated with the production and distribution thereof, provided that such costs and expenses shall be funded by VFLLC, if required under the terms of the Funding Arrangement; and (x) purchase any prescription data required to monitor Product Revenues by distribution channel; provided, however, that costs of purchase of such prescription data, to the extent included in the Product Budget, shall be borne by Ventiv.