Product Launch and Market Coverage Sample Clauses

Product Launch and Market Coverage. Provided there are no regulatory or legal disputes or issues related to the Commercialization of the Product and provided Galena has on hand enough approved and saleable Product to successfully launch the Commercialization of the Product consistent with the forecasts delivered by Galena in accordance with Section 6.5.1 then Galena will use Commercially Reasonable Efforts to begin its Commercialization of the Product on or before December 31, 2014. Until such time as (i) the previous rolling twelve (12) months net sales for Galena exceeds [***] million dollars ($[***]) or (ii) there is a Competing Product approved by the FDA and be placed into the market for sale, Galena will maintain a minimum Average Field Force of [***] ([***]) Field Personnel with a minimum of [***] percent ([***]%) of a sales representative’s commission plan based on the Product. SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS ([***]) DENOTE SUCH OMISSIONS. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMITTED INFORMATION.
Sample 1
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Product Launch and Market Coverage. Provided there are no regulatory or legal disputes or issues related to the Commercialization of the Product and provided Galena has on hand
Sample 1
Product Launch and Market Coverage. Pharmanovia shall use its Commercially Reasonable Efforts to launch the Product in the applicable country in the Territory within sixty (60) days of receiving the first delivery of saleable, Product following the later of pricing reimbursement and receipt of the Regulatory Approval of such Product in such country in the Territory. Aquestive acknowledges that it shall be consistent with Commercially Reasonable Efforts for Pharmanovia to prioritize Commercialization of the Product in certain countries of the Territory and not to proceed with Commercialization of a Product in all countries of the Territory at the same planned timetable. 3.4
Sample 1
Product Launch and Market Coverage. Provided there are no regulatory or legal disputes or issues related to the Commercialization of the Product and provided the Product has been delivered to Dara according to the purchase order and to the terms of this Agreement then Dara will begin active Commercialization of the Product in all major market segments no later than six (6) months after the Effective Date. During the first eighteen (18) months after the First Commercial Sale, Dara shall maintain a minimum of twenty (20) full time equivalents in its sales and marketing functions for the Product covering the principal cancer treatment centers in the major metropolitan areas of the Territory. Dara’s Co-promotion Partner shall maintain a minimum of twenty-four (24) full time equivalents to serve the general practitioner market, each of whom shall have the background, training and knowledge required to facilitate the successful Commercialization of the Product in the Territory. Should a generic equivalent product be approved by the Regulatory Authority, and Dara provides reasonable evidence that the generic equivalent product has achieved a unit market share of ten percent (10%) or more, the minimum full time equivalent requirement shall be waived and Dara shall have the right to terminate this Agreement upon the provision of written notice to Onxeo, in which case Onxeo shall, on Dara’s first request by notice, cancel previously placed purchase orders for the Product, provided, however, that Dara shall advance to Onxeo any costs, determined on a pass-through basis, reasonably incurred by Onxeo in connection with the cancellation of such orders.
Sample 1
Product Launch and Market Coverage. Haisco will use its best efforts to launch the Product within the Territory within ninety (90) days of receipt of the Marketing Authorization 6.4
Sample 1

Related to Product Launch and Market Coverage

  • Launch Customer shall use commercially reasonable efforts to begin distribution of the Google Desktop Applications promptly following the launch of the Desktop Portal.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

  • Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Product The term “

  • Data Loss Prevention Transfer Agent shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving Transfer Agent’s control without authorization in place.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

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