Contract Manufacture a) POLYMER may have SCJ LICENSED PRODUCTS manufactured for it by another party (subject to the prior written approval of SCJ and to the terms and conditions of this Agreement). POLYMER shall request SCJ’s approval to use a third party contract manufacturer or packer by submitting a written request to SCJ in accordance with the provisions of Section 23 below. Notwithstanding the foregoing, the third parties listed on Schedule 8(a)-1 have been pre-approved by SCJ to act as contract manufacturers and packers for POLYMER for those SCJ LICENSED PRODUCTS appearing next to their names on such schedule. Any approved contract manufacturer or packer may affix, on behalf of POLYMER, CHEMICAL MARKS to the pre-approved SCJ LICENSED PRODUCTS. Such other party shall not be obligated to obtain separate trademark licenses from SCJ with respect to products so manufactured on behalf of POLYMER. POLYMER shall enter into a written contract manufacturing agreement with such other party, which shall include, among other things, the provisions set forth in Schedule 8(a)-2 attached hereto. Except as set forth in Section 8(c) below, POLYMER shall have the right to determine which SCJ LICENSED PRODUCTS, if any, shall be Table of Contents manufactured for it by other parties for distribution and sale by POLYMER in accordance with this Agreement.
b) Notwithstanding the foregoing, in the event SCJ reasonably determines that one or more SCJ LICENSED PRODUCTS being manufactured or packaged for POLYMER by a contract manufacturer or packer are being diverted outside the CHEMICAL SALES CHANNELS OF TRADE in one or more countries, SCJ shall notify POLYMER thereof. POLYMER shall have sixty (60) days in which to ensure that any such diversion has ceased and to provide SCJ with satisfactory evidence thereof. If SCJ is satisfied that such diversion has ceased, the third party contract manufacturer or packer shall retain its approved status with respect to such SCJ LICENSED PRODUCT(S). If, on the other hand, SCJ is not satisfied that diversion of such SCJ LICENSED PRODUCT(S) has ceased in those countries, POLYMER shall be obligated to terminate that contract manufacturer’s or packer’s rights with respect to such SCJ LICENSED PRODUCT(S) and another approved contract manufacturer, as mutually agreed, shall supply such SCJ LICENSED PRODUCT(S) for sale in such countries.
c) In the event an approved contract manufacturer or packer fails to meet the quality standards required under this Agreement, SCJ s...
Contract Manufacture. Notwithstanding the provisions of this clause 3, Medigen may sub-contract the manufacture of Products or components of Products to a Third Party contract manufacturing organisation located in the Territory, provided that such manufacturer has agreed to be bound by obligations at least as onerous as those set out in clauses 6.6 (Care and Skill) and 15 (Confidentiality).
Contract Manufacture. UNDP must approve the site(s) of contract manufacture(s) and any changes thereof.
Contract Manufacture. Distributor acknowledges that Manufacturer may use an Affiliate or one or more Third Parties to supply, contract manufacture or package the Products (collectively, “Third Party Vendors”). *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Contract Manufacture. 4.1 Subject to Clause 4.2, Baxter hereby exclusively appoints Oravax to Manufacture Xxxxxx’x and all members of its Group’s requirements for the Products and Oravax accepts such appointment. During the term of this Agreement, Oravax will Manufacture for Xxxxxx’x Group the Products in accordance with this Agreement and Baxter shall and shall procure that Xxxxxx’x Group:
4.1.1 acquire all their requirements for the Products exclusively from Oravax; and
4.1.2 do not themselves Manufacture or have Manufactured the Products other than as set out in this Agreement.
4.2 Oravax’s exclusivity as set out in Clause 4.1 shall not apply in the circumstances set out in Clause 20.3 or in relation to a particular Product that Oravax is unable to Manufacture within twelve (12) months of the date of commencement of Process Development for that particular Product. Back to Contents
4.3 Oravax shall:
4.3.1 supply all information to and otherwise cooperate with Baxter, as reasonably required by Baxter, to maximise the likelihood of Xxxxxx’x success in obtaining a BLA including but not limited to the FDA’s pre-approval inspection of the Canton Facility;
4.3.2 Manufacture the Products using the Process in accordance with the Specifications;
4.3.3 ensure that any materials employed by Oravax in the Manufacture and not supplied by or on behalf of Baxter will at the time of use comply with the Specifications;
4.3.4 allow, once in every three (3) months during the period of this Agreement or at such other times to satisfy the Agency and during normal business hours and upon reasonable notice, authorised representatives of Baxter reasonably acceptable to Oravax to inspect the relevant parts of its premises where the Manufacture of the Products is carried out or the Products or Working Seeds are stored, to inspect the process of Manufacture, and to inspect any documentation relating to compliance with GMP or to the safety, purity or potency of the Product. The costs of such inspection shall be payable by Baxter. Notwithstanding the foregoing, Oravax’s obligation to allow such visitors is on condition that: (a) Baxter procures that such visitors agree in writing to observe the requirements of Oravax regarding security, health and safety, confidentiality or any other applicable regulations at the relevant premises; (b) any visit shall be under the specific supervision of Oravax (without relieving any visitors of any obligations with respect to any damage or injury caused by them); (c) Ba...
Contract Manufacture. If Regulus intends to contract one or more Third Parties to conduct any manufacturing activities with respect to any Licensed Compound or Product in support of a POC Program, and prior to entering into a definitive agreement with a Third Party with respect to the conduct of such manufacturing activities, in each case, Regulus shall so notify Sanofi no later than the time Regulus submits a request for quotation or proposal to any such Third Party(ies) for those manufacturing activities, shall provide Sanofi with the same information that Regulus provides to any such Third Party(ies) for the purpose of such Third Party’s(ies’) preparation of such quotation or proposal, and shall inform Sanofi of the date by which Regulus expects to select a contract manufacturer to perform such manufacturing activities (collectively, the “Request for Proposal”). If Sanofi is interested in performing, or having one of its Affiliates perform, such manufacturing activities, Sanofi may, in its sole discretion, submit a quotation or proposal to Regulus. Regulus shall consider in good faith such quotation or proposal from Sanofi, but Regulus shall be free to select the quotation or proposal (whether of Sanofi or of any Third Party) that Regulus, in its sole discretion, deems to be in Regulus’ best interests, provided, however, that Regulus shall not select any Third Party quotation or proposal that (taken as a whole) is less favorable to Regulus than the last quotation or proposal received from Sanofi and Regulus shall give Sanofi the opportunity to match any Third Party quotation or proposal that (taken as a whole) is more favorable to Regulus than the last quotation or proposal received from Sanofi. If Regulus accepts a quotation or proposal provided by Sanofi, the Parties shall negotiate and enter into a separate agreement governing the performance such manufacturing activities. If Sanofi does not submit a quotation or proposal to Regulus within […***…] days after the Request for Proposal, or notify Regulus that it wishes to match a more favorable Third Party quotation or proposal within […***…] days after Regulus communicates such Third Party proposal to Sanofi, then Regulus shall be free to enter into a definitive agreement with a Third Party with respect to the conduct of such manufacturing activities. For clarity, this Section 4.1.1 shall not apply to any manufacturing activities with respect to which Regulus has contracted with any Third Party as of the Second Restatement ...
Contract Manufacture. The Licensee may enter into a sub-contract for the research, development and manufacture of Products or parts of Products within the Territory on behalf of the Licensee and may sub-license the Licensed IP to the extent necessary for such purpose, provided the Licensee remains responsible for ensuring compliance with the terms and conditions of this Agreement.
Contract Manufacture. 2.1. Aviron hereby appoints Xxxxx and Xxxxx accepts the appointment as Manufacturer of the Product for the term of this Agreement. During the period of this Agreement Xxxxx will Manufacture for Aviron the Product in accordance with this Agreement and the Technical Agreement.
2.2. Aviron shall be responsible for and shall bear all risks associated with the importation and supply to Xxxxx of the Virus Seeds into the United Kingdom. Aviron shall be responsible for export of the Product from the United Kingdom and any costs and expenses associated therewith or relevant thereto. Xxxxx shall assist at Aviron's reasonable request and at Aviron's expense with the export of the Product from the United Kingdom.
2.3. Xxxxx covenants that:
2.3.1. it will carry out the Manufacture in accordance with this Agreement and the Technical Agreement;
2.3.2. all Raw Materials supplied by Xxxxx and used in Manufacture will comply with the Technical Agreement;
2.3.3. it will keep under review the conditions of the Virus Seed, Raw Materials and Product in storage as such conditions are defined in the Technical Agreement;
2.3.4. it will upon written request of Aviron, and at Aviron's expense, supply Aviron with samples of the Product Manufactured by it prior to delivery of ordered Product;
Contract Manufacture the formulation, filling, sterilization, and primary and secondary packaging of the Product and as applicable, quality control testing (including in-process, release and follow up stability testing and release and shipping of Product to meet Specifications and requirements of the Marketing Authorisation for the Product) for each given area of the Territory after the Marketing Authorisation for the Product has been obtained from the relevant Regulatory Authority for that area of the Territory.
Contract Manufacture. 4.1. During the Term, IMMUCELL:
4.1.1. agrees to supply NORBOOK, free of charge, with the materials to be obtained by it for Contract Manufacture (as set forth in the Technical Agreement at Schedule 4), in particular the API and Primary Packaging, and undertakes to ensure that the same will comply with the standard set out in the Specifications and the Marketing Authorisation, will be fit for use and will be in sufficient quantities to satisfy Contract Manufacture requirements;
4.1.2. shall be solely responsible for all text and art work for the labels, cartons and containers to be used for the Product and will supply all artwork for the making of the packaging materials;
4.1.3. warrants that the relevant text and artwork as specified by it complies with the requirements of the relevant Marketing Authorisation and the statutory and other legal requirements of each particular relevant area of the Territory in which the Product is to be marketed and sold and furthermore does not infringe any third party intellectual or industrial property rights and hereby indemnifies and shall hold NORBROOK harmless against all claims, liabilities and costs arising from the inaccuracy of the statements contained in this Section 4.1.3;
4.1.4. undertakes to purchase the Product from NORBROOK and not to perform the tasks contemplated to be performed by NORBROOK on its own account, or have another person or entity perform such tasks, except as expressly provided for in this agreement;
4.1.5. undertakes, in each Year of the Term, to purchase from NORBROOK the Minimum Purchase Quantity at the relevant Price and/or, at IMMUCELL’s sole option, to pay to NORBROOK the Deficit Rate with respect to any shortfall relative to the applicable Minimum Purchase Quantity in accordance with Clause 6 and Schedule 3 Part C.
