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.

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.

Related to New Products in the Facility

Third Party Products and Services Any third-party hardware, software and/or services that is delivered by ResMed for use either standalone or in conjunction with ResMed products and/or services, shall be subject to the third-party terms and conditions and/or license agreements between Customer and the third party. Such third-party hardware, software and/or services is provided by ResMed "AS IS," without any warranty of any kind. Any representations or warranties as to such hardware, software and/or services shall only be as granted by the applicable third parties, if any, that accompany such products and/or software and/or services. Any representations, warranties, or other similar obligations with respect to such third-party hardware, software and/or services flow directly from the third party to Customer and ResMed shall have no responsibility at all for any such representations, warranties, obligations or lack thereof.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
Other Products and Services As our customer, you have access to a suite of financial products and services availed by ourselves, our affiliates and strategic partners designed to help you address and achieve your financial needs and goals. You agree that you can obtain information about such Products and Services via our website xxx.xxxxxxxx.xxx.xx and you further agree that we can from time to time communicate information in relation to such Products or Services to you specifically or generally to all cardmembers via such communication mode as we consider appropriate.
Additional Products and Services Subject to the allocation of funds, the CPO may add similar equipment, supplies, services, or locations, within the scope of this Agreement, to the list of equipment, supplies, services, or locations to be performed or provided by giving written notification to Contractor. For purposes of this Section, the “Effective Date” means the date specified in the notification from the CPO. As of the Effective Date, each item added is subject to this Agreement, as if it had originally been a part, but the charge for each item starts to accrue only on the Effective Date. In the event the additional equipment, supplies, services, or locations are not identical to the items(s) already under this Agreement, the charges therefor will then be Contractor’s normal and customary charges or rates for the equipment, supplies, services, or locations classified in the Fees and Costs (Exhibit “F”).
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 Products available under this Contract are limited to Software, including Software as a Service, products and related products as specified in Appendix C, Pricing Index. Vendor may incorporate changes to their product offering; however, any changes must be within the scope of products awarded based on the posting described in Section 1.B above. Vendor may not add a manufacturer’s product line which was not included in the Vendor’s response to the solicitation described in Section 1.B above.
Products and Services General Information
Third Party Products 12.1 Third-party products provided to you by NCR Voyix for use with your subscription to the Service are subject to any terms provided by their supplier, including but not limited to those terms and conditions set forth in the exhibits attached hereto. Third-party terms and conditions are subject to change at any time by the supplier, and you agree that your use of such third-party products and services is governed by such supplier’s terms and conditions. You hereby release NCR Voyix from any and all liability associated with any damages or claims arising out of or related to third-party products. UNLESS NCR Xxxxx SPECIFICALLY AGREES OTHERWISE IN WRITING, YOU ACKNOWLEDGE AND AGREE THAT SUCH THIRD-PARTY PRODUCTS ARE PROVIDED “AS-IS” WITHOUT A WARRANTY FROM NCR Voyix. ACCORDINGLY, NCR Voyix EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY NATURE WITH RESPECT TO ANY SUCH THIRD-PARTY PRODUCTS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF ANY THIRD-PARTY RIGHTS. 12.2 Third-party products and services may be advertised or made available to you for purchase directly from their supplier by email or other electronic communications, including notifications made through the Service or the Account Portal. Any representations or warranties that may be provided in connection with any such third-party products or services are provided solely by their supplier. NCR Voyix will not be responsible for any of your dealings or interactions with any of those third-party suppliers.
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.