Labeling and Packaging BTG shall label and package the Bulk Product in accordance with Legal Requirements applicable to pharmaceutical products shipped in bulk for further processing, labeling, or repackaging.
Packaging and Labeling 11.1 Company shall provide packaging and labeling specifications that call out clear labeling requirements.
Packaging All Material shall be packaged in accordance with ATA 300 Specification, Category III for consumable/expendable material and Category II for rotables. Category I containers shall be used if requested by the Buyer and the difference between Category I and Category II packaging costs shall be paid by the Buyer together with payment for the respective Material.
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.
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.
Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:
Forecasts and Purchase Orders On or before the twelfth (12th) day of each month, beginning on January 12, 2022, Indivior shall furnish to Curia a written twelve (12) month rolling forecast of the quantities of Product that Indivior intends to order from Curia during such period ("Rolling Forecast"). The first six (6) months of such Rolling Forecast shall constitute a firm and binding commitment to order quantities of Product specified therein ("Firm Period Forecast"), and the following six (6) months of the Rolling Forecast shall be non-binding, good faith estimates. Each month of the Rolling Forecast shall begin on the twelfth (12th) of the calendar month in which such Rolling Forecast is submitted and end on the eleventh (11th) day of the following calendar month. With exception to the Firm Period Forecast, Curia reserves the right to reject any Rolling Forecast that does not align with the physical Processing capabilities of the Facility(ies) and the parties shall work in good faith to adjust the Rolling Forecast based on available resources, Facility capacity and other relevant factors. Indivior shall have the right to request an increase of the Firm Period Forecast to include additional units of Product. Curia may, in its sole discretion, supply such additional quantities, subject to Curia's other supply commitments and manufacturing capacity. In the event Curia agrees to supply such additional quantities, Indivior shall submit a Purchase Order for such additional quantities, with the required lead times as specified below. In no event shall Curia's inability to fulfill Purchase Orders for quantities in excess of the Firm Period Forecast be deemed a breach of this Agreement, nor relieve Indivior of its obligations under this Agreement. Indivior shall submit with each Rolling Forecast, a non-cancelable Purchase Order for the Firm Period Forecast (or such portion of the Firm Period Forecast not covered by previously submitted Purchase Orders). Indivior may alternatively submit Purchase Orders for certain portions of the Firm Period Forecast subsequent to the submission of the Rolling Forecast, provided the Purchase Orders provide the required lead time for Processing as set forth below. Curia shall notify Indivior of acceptance of the Rolling Forecast and any Purchase Order within seven (7) business days of receipt. Curia shall be deemed to have accepted Purchase Orders which it does not acknowledge within seven (7) business days of receipt. Curia shall have the right to reject Rolling Forecasts and Purchase Orders that are inconsistent with this Agreement. Each Purchase Order shall specify the quantity of Product being ordered, and the desired delivery date. Upon mutual agreement in writing for additional quantities of Product beyond the Firm Period Forecast, including projected delivery date(s), Indivior shall issue the applicable Purchase Order to be accepted by Curia as described above. Once placed, all Purchase Orders for Product shall be non-cancelable. No different or additional terms or conditions set forth in any Purchase Order shall modify in any way the terms and conditions of this Agreement, and in the event of a conflict between terms in any Purchase Order and this Agreement, the terms of this Agreement shall control. All Purchase Orders submitted in accordance with the terms of this Agreement shall be effective and binding on the parties upon acceptance by Curia. Except as otherwise provided herein, neither party shall have the right or power to refuse, reduce, or otherwise modify their obligations under any Purchase Order; however, Purchase Orders may be amended (i) upon written mutual agreement regarding such modification that is signed by both parties; or (ii) as otherwise provided in this Section 4.3 or Section 4.4.
Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.
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.
Marketing Materials (a) During the term of this Agreement, the Sub-Adviser agrees to furnish the Manager at its principal office for prior review and approval by the Manager all written and/or printed materials, including but not limited to, PowerPointÒ or slide presentations, news releases, advertisements, brochures, fact sheets and other promotional, informational or marketing materials (the “Marketing Materials”) for internal use or public dissemination, that are produced or are for use or reference by the Sub-Adviser, its affiliates or other designees, broker-dealers or the public in connection with the Series, and Sub-Adviser shall not use any such materials if the Manager reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. Marketing Materials may be furnished to the Manager by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery.
