Manufacturing Assumptions Sample Clauses

Manufacturing Assumptions. 1.1 The manufacturing process at Patheon will closely follow the process information provided by Client.
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Manufacturing Assumptions. 1. The commercial process at Patheon will closely follow the manufacturing information provided by Reliant.
Manufacturing Assumptions. 1.1 The manufacturing process at Patheon will closely follow the process information provided by Supernus and Patheon’s best estimates.
Manufacturing Assumptions. The manufacturing process at Patheon will follow the process information provided by Pozen and Patheon’s experience with the product. · The core tablet weight and manufacturing batch sizes for each strength proposed by Patheon are summarized in the following table. · Pricing for both a 503 and 1250Kg batch size is being presented for comparison purposes. Testing Assumptions · *** for *** and *** are *** on ***. · It is *** that the *** would only be required to *** of the ***. *** can fully *** and this *** can be ***. · It is *** that *** are *** and ***. · Each *** has *** to the ***. · *** has been included on the finished product. · *** may be subject to change after the *** on *** and ***. Cleaning Assumptions · It is *** that *** are *** and *** after each campaign. The following cost items are included in the Price for the Products: *** and *** ***of *** ***of *** *** *** for *** ***, and *** thereafter CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION *** and *** *** of the *** *** and *** *** *** of *** and other *** for *** *** of *** and other *** for *** or *** *** *** and *** of *** and *** *** of *** and *** for *** *** and *** by *** to be *** by *** and***.
Manufacturing Assumptions. 1.1 The manufacturing process at Patheon will closely follow the process information provided by Salix and work performed to-date at the site.
Manufacturing Assumptions. Patheon will use the following manufacturing equipment train in the Manufacturing Process and for production of the TIMERxâ-N Product. [**] • There will be [**]. Final blending will be performed in the [**]. • Single Batch manufacturing runs are anticipated. Each Batch will yield approximately [**] kilograms of TIMERxâ-N. • Patheon assumes that the TIMERxâ-N Formulation does not absorb/adsorb to any metal, glass or other components used during the processing and analytical testing of the Batch. • Patheon assumes the current cleaning procedure is adequate and full cleaning occurs after each campaign. • A manufacturing yield of [**] percent ([**]%) is expected based on Penwest’s prior experience with the Manufacturing Process. • Patheon shall conduct finished Product testing on all Product Batches, in accordance with the Manufacturing Process, cGMPs and Specifications, such testing to include: [**]. • As per Penwest, granulation will be bulk packaged into approximately [**] drums double lined with [**].

Related to Manufacturing Assumptions

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacturing Costs In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, Merck shall be entitled to [*****] (as defined herein) incurred by Merck for its Compound Delivered for the Study. [*****]

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

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