New Products in the Facility Sample Clauses

New Products in the Facility. Xxxxxxxxxx recognizes that the addition of new products into its multi-product facilities could have an impact on the regulatory status of Drug Substance and Drug Product. Xxxxxxxxxx has developed and adheres to the Position Statement “Product Separation of High Potent Drug Products and Active Pharmaceutical Ingredients” (the "Position Statement" as attached in Appendix D). If Xxxxxxxxxx makes any changes to the Position Statement, it will provide written notification to Dyax within [*****] calendar days. After the earlier of the first Pre-Approval Inspection by any Regulatory Agency for the Product is completed, or the first Marketing Application is submitted, Xxxxxxxxxx will provide to Dyax as a part of the PQR the number of products introduced that year and their substance category as defined in Appendix D. This annual notification will occur within [*****] days of the anniversary date of the marketing authorization approval.
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New Products in the Facility. Xxxx recognizes that the addition of new products into its multi-product facilities could have an impact on the regulatory status of Drug Product. Xxxx will provide to Dyax information about the class of new products, but will not provide other clients’ confidential information, as agreed in the Quality Agreement. For the avoidance of doubt, the Parties agree that Xxxx will notify Dyax within [*****] prior to any other product introduced into the Facility to allow for proper assessment of such product’s impact on Drug Product Production and notification of applicable Regulatory Authorities.
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New Products in the Facility. Fujifilm recognises that the addition of new products into its multi-product facilities could have an impact on the regulatory status of Drug Product. During the period whilst there is a supply agreement in place between Dyax and Fujifilm for the commercial supply of Bulk Drug Substance, Fujifilm will assess all new product entries prior to manufacture for impact on the regulatory status of the Bulk Drug Substance. Fujifilm will update its Drug Master File with details of each new product introduction into either the GMP manufacturing suites and/or equipment shared with Bulk Drug Substance fermentation and downstream purification steps. Fujifilm will notify Dyax in writing of these and provide sufficient summary information to allow Dyax to complete the relevant submissions to the FDA. Should it be deemed necessary, Third Party confidential information will be disclosed directly to the FDA via the Drug Master File. Where the Fujifilm regulatory assessment deems that a Prior Approval Supplement to the Dyax Biologics License Application may be required as a result of a planned new product introduction, Fujifilm will notify Dyax in writing at the earliest opportunity in order to allow consideration of the regulatory strategy and timelines. Dyax will use Commercially Reasonable Efforts to submit a Prior Approval Supplement to the FDA within ten (10) Business Days of receiving notification of such a new product. Should the FDA require further explanation or information to support their decision this will be provided by Fujifilm. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.
Sample 1

Related to New Products in the Facility

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Competitive Products Competitive Products" means products that serve the same function as, or that could be used to replace, products the Company provided to, offered to, or was in the process of developing for a present, former, or future possible customer/partner at any time during the twelve (12) months immediately preceding the last day of Participant's employment (or at any time during Participant's employment if Participant was employed for less than 12 months), with which Participant had direct responsibility for the sale or development of such products or managing those persons responsible for the sale or development of such products.

  • Products 1.1. The information (including but not limited to the quantity, rated hashrate, unit price (“Unit Price”), total price for one item (“Total Price (One Item)”), total price for all the items (“Total Purchase Price”) of Products to be purchased by Party B from Party A is as follows (“Products”):

  • Products and Services Part 2.9(a) of the Disclosure Schedule accurately identifies and describes each Company Product currently being designed, developed, manufactured, marketed, distributed, provided, licensed, or sold by the Company.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Borrower Products Except as described on Schedule 5.11, no Intellectual Property owned by Borrower or Borrower Product has been or is subject to any actual or, to the knowledge of Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of Borrower or Borrower Products. Borrower has not received any written notice or claim, or, to the knowledge of Borrower, oral notice or claim, challenging or questioning Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s knowledge, is there a reasonable basis for any such claim. Neither Borrower’s use of its Intellectual Property nor the production and sale of Borrower Products infringes the Intellectual Property or other rights of others.

  • Other Products After clinical or other evidence, provided in writing [***] to Company, demonstrating the practicality of a particular market or use within the LICENSED FIELD which is not being developed or commercialized by Company, Company shall either provide JHU with a reasonable development plan and start development or attempt to reasonably sublicense the particular market or use to a third party. If within six (6) months of such notification [***] Company has not initiated such development efforts or sublicensed that particular market or use, JHU may terminate this license for such particular market or use. This Paragraph shall not be applicable if Company reasonably demonstrates to JHU that commercializing such LICENSED PRODUCT(S) or LICENSED SERVICE(S) or granting such a sublicense in said market or use would have a potentially adverse commercial effect upon marketing or sales of the LICENSED PRODUCT(S) developed and being sold by Company.

  • Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.

  • Proceeds and Products All proceeds, including insurance proceeds, and products of the items of Credit Security described or referred to in Sections 2.1.1 through 2.1.14 and, to the extent not included in the foregoing, all Distributions with respect to the Pledged Securities.

  • Additional Products Throughout the Term, Rockwell shall provide to DaVita and the DaVita Facilities the right to purchase and/or lease all current or new products manufactured, utilized, licensed, sold or distributed by Rockwell or any of its Affiliates (including products and product lines acquired by Rockwell or any of its Affiliates as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates) that are or that become Commercially Available and which are not already covered by this Agreement or by any other agreement, whether written or oral, between the parties hereto (such products are collectively referred to as “Additional Products” and individually as an “Additional Product”). Rockwell agrees to include DaVita in all of its and its Affiliates distributions of customer announcements regarding Rockwell’s or its Affiliates’ Additional Products. The purchase price for any such Additional Products shall be negotiated by the parties hereto in good faith and the agreed upon purchase price shall be memorialized in writing as a supplement or amendment to this Agreement. Rockwell covenants and agrees that it shall only make an offer for the sale of any Additional Product(s) to DaVita’s Vice-President of Clinical Operations, Chief Medical Officer, or Vice-President of Purchasing, and not to any DaVita Facility directly; provided that the purchase of any Additional Product by DaVita or any DaVita Facility through a Rockwell product catalog made generally available to the dialysis community shall not be a breach by Rockwell of this Section 8.1. If Rockwell or any of its Affiliates acquires any Additional Product(s) as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates with a Person with which DaVita or a DaVita Facility, as applicable, already has a purchase or rebate arrangement whether written or oral (a “Prior Agreement”), Rockwell or such Affiliate covenants and agrees that it shall continue to abide by all of the terms and conditions of such Prior Agreement or if DaVita requests, such Additional Product(s) shall be included in this Agreement on terms to be negotiated and determined by the parties hereto as provided in this Section 8.1.

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