Contract
Exhibit 10.21
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. THE OMISSIONS HAVE BEEN INDICATED BY “[***].”
SUPPLY AND
PACKAGING SERVICES AGREEMENT
by and between
0000 X. Xxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxx, XX 00000, U.S.
and
Sandoz GmbH
Xxxxxxxxxxxxxxxx 00, 0000 Xxxxx, Xxxxxxx
1.SCOPE AND STRUCTURE OF THIS AGREEMENT3
2.SET-UP ACTIVITIES4
3.PACKAGING AND SUPPLY5
4.CUSTOMER SUPPLIED MATERIALS6
5.FORECASTING, ORDERS AND DELIVERY7
6.PRICES AND PAYMENT TERMS9
7.INTELLECTUAL PROPERTY 10
8.WARRANTIES AND DEFECTIVE PRODUCT11
9.INDEMNIFICATION AND LIABILITIES14
10.QUALITY14
11.PHARMACOVIGILANCE15
12.CONFIDENTIALITY15
13.TERM AND XXXXXXXXXXX00
00.GOVERNING LAW AND JURISDICTION16
15.MISCELLANEOUS17
Annex 1 – Definitions and Interpretation
Annex 2 – Letter of Intent
Annex 3 – Further Implementation Services
Annex 4 – Bulk Specifications
Annex 5 – Packaging Process
Annex 6 – Prices
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This Agreement is made on the date of the last signature of the Parties below (the “Effective Date”)
(1) |
Sandoz GmbH, a limited liability company organized and existing under the laws of Austria, registered with the commercial register of the district court (Landesgericht) Innsbruck under FN 50587v, with its registered address at Xxxxxxxxxxxxxxxx 00, 0000 Xxxxx, Xxxxxxx (“Supplier”); and |
(2) |
Phathom Pharmaceuticals, Inc, a corporation validly existing under the laws of the State of Delaware, located at 0000 X. Xxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxx, XX 00000, U.S. (“Customer”). |
(A) |
Customer is engaged in the marketing and sales of pharmaceutical products. |
(B) |
Supplier is a company engaged inter alia in the manufacturing of pharmaceutical products, including the manufacture of bulk products and provision of packaging services for pharmaceutical products. |
(C) |
Customer desires to entrust Supplier to supply certain bulk products and to perform certain packaging services relating to certain proprietary pharmaceutical products pursuant to the terms and conditions of this Agreement. |
Vonoprazan 20 mg FCT shall be provided by Customer (the “Customer Provided Bulk Products”), whereas Clarithromycin 500 mg FCTs, Amoxicillin 500 mg HGCs shall be provided by Supplier (the “Supplier Provided Bulk Products”).
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that at all times Supplier shall remain the principal obligor for the performance of Supplier’s obligations under this Agreement to the extent not satisfied by an Affiliate of Supplier. This shall include the possibility for Supplier to nominate an Affiliate for order placement and invoicing purposes. Notwithstanding the foregoing, if within [***] following receipt of a notice referred to in the first sentence of this Clause 1.5, Customer notifies Supplier in writing that such proposed Affiliate subcontract by Supplier could impact the Registration for the Final Product, then Supplier agrees not to proceed with such subcontract absent Customer’s prior written consent, which consent shall not be unreasonably delayed, withheld or conditioned, and the Parties will work together in good faith on a plan that would allow Supplier to proceed with such subcontract without impacting the Registration for the Final Product. |
1.7 |
Extension of Scope. The cooperation of the Parties shall in the first instance be limited to Packaging Services, and other services, related to the Final Product to be marketed in the Territory (as defined below). However, Customer intends potentially to launch the Final Product in other regions, and to launch the Additional Product in the Territory and potentially in other regions. In case of such additional launches the scope of this Agreement shall be extended, and the terms modified, solely to the extent necessary to address such expanded scope, e.g., for the Additional Product the Parties would need to agree, among other things, to set up activities, specifications, and pricing, all of which are subject always to mutual agreement of the Parties. |
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(a) |
Validation of the Packaging Process; and |
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(b) |
Stability Study for Submission. |
2.4 |
[***] |
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3.1 |
Commencement. Upon completion of the Set-up Activities (except for the stability study) and subject to payment of the Implementation Fees, Supplier shall provide the Packaging Services and Deliver Final Products to Customer and its Affiliates throughout the remaining Term. Supplier hereby agrees to supply to Customer and Customer agrees to purchase and accept delivery of the Final Product on the terms and subject to the conditions of this Agreement. |
3.3 |
Packaging Process. The Packaging Process to be followed by Supplier when providing the Packaging Services is defined in Annex 5 (Packaging Process). |
3.4 |
Materials and Equipment. Unless explicitly provided otherwise herein, Supplier shall be responsible for procuring or having available, at its own cost, any and all materials and Equipment necessary for the Packaging Services and the Supplier Bulk Supply, including, for the avoidance of doubt, any Packaging Materials. |
3.5 |
Artwork and Packaging. Customer shall provide or approve, prior to the procurement of applicable components, all artwork and packaging information necessary to Package the Final Product. Customer shall provide artwork for all printed materials (e.g., blister design, cartons, labels and leaflets) at least [***] prior to the placement of the respective Purchase Order. In case of changes in the artworks, text of the package inserts or labeling, Customer shall compensate Supplier [***]. Supplier shall be notified of all changes specific to artworks, package inserts or labeling sufficiently in advance of implementation to allow time for process documentation changes and stock control. Any artwork, advertising and packaging information is and shall remain the exclusive property of Customer, and Customer shall be solely responsible for the content thereof and hold Supplier harmless against any third party claims arising from the use of such artwork etc. in the provision of services hereunder. Such artwork and packaging information or any reproduction thereof may not be used by Supplier following the termination of this Agreement, or during the Term of this Agreement in any manner other than solely for the purpose of performing its obligations hereunder. |
3.6 |
Registration and Regulatory Requirements. Customer and its Affiliates shall be responsible for the Registration of the Final Product with all relevant Regulatory Authorities of all countries of the Territory where they market Final Product. Supplier shall, at Customer’s cost, provide such assistance and information as Customer or its Affiliates may reasonably request in connection therewith, including the grant of a letter of authorization for Supplier’s ANDAs. |
3.8 |
Affiliate Ordering. Supplier agrees that Customer’s Affiliates may order Final Products directly from Supplier in accordance with the terms and conditions of this Agreement, and |
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request that Final Products be Delivered directly to such Customer Affiliate together with the appropriate invoices. Any Order placed by a Customer Affiliate and accepted by Supplier shall form a separate and distinct agreement between the parties to such Order. References to either Party in the terms and conditions of this Agreement shall be read as references to the respective Party to any Order for the purpose of said Order. Only the parties to an order shall be bound by such Order. |
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own costs. Customer shall hold Supplier harmless of any actual, documented losses (including due to production downtime) to the extent directly resulting from such defects or non-conformity, after Supplier has made reasonable good faith efforts to mitigate any such losses (including due to production downtime). |
5.2 |
Order Placement and Order Lead Time. Customer shall, from time to time throughout the Term of this Agreement, place written orders for Final Products subject to the terms and conditions of this Agreement (the “Order(s)”). Any Order must be submitted with a lead time of at least [***] prior to the earliest Requested Delivery Date (the “Order Lead Time”) and shall set forth the requested quantities of the Final Product (the “Requested Order Quantities”) and the requested Delivery date(s) in accordance with such Order Lead Time (the “Requested Delivery Date(s)”). |
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The Minimum Purchase Quantities for later Launch Years shall be mutually agreed by the Parties at least [***] prior to the end of Launch Year 2. In case the Parties fail to reach an agreement by such date, each Party may terminate this Agreement on [***] prior written notice.
In case Customer fails to order the agreed Minimum Purchase Quantity in a given Launch Year, Customer shall pay to Supplier the difference between the respective aggregated Price (plus VAT) of (i) the quantity of Final Products actually ordered by Customer from Supplier during such Launch Year and (ii) the respective Minimum Purchase Quantity, unless such failure is directly caused by an act or omission solely attributable to Supplier.
5.9 |
No Returns Policy. Supplier will not accept the return of any Final Product sold to Customer except in relation to Defective Final Products and Supplier shall not be liable to Customer in respect of any Final Product purchased by Customer which Customer is subsequently unable to resell. |
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6.7 |
Unpaid Invoices. Upon expiration or termination of this Agreement all outstanding unpaid invoices shall become payable immediately in place of the payment terms previously agreed by the Parties. |
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(a) |
The Packaging Process and the Bulk Specifications relating to the Customer Provided Bulk Products; |
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(b) |
Any Intellectual Property rights relating to the Final Product and the Customer Provided Bulk Products; |
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(c) |
The artwork, advertising and packaging information relating to the Final Product; and |
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(d) |
Any other Intellectual Property solely invented, discovered, generated or derived by Customer or its Affiliates under or in connection with this Agreement and/or the Final Product. |
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(a) |
The manufacturing process of Supplier Provided Bulk Products and the Bulk Specifications relating to the Supplier Provided Bulk Products; |
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(b) |
Any Intellectual Property rights relating to the Supplier Provided Bulk Products; and |
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(c) |
Any other Intellectual Property solely invented, discovered, generated or derived by Supplier or its Affiliates under or in connection with this Agreement and/or the Supplier Provided Bulk Products. |
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(a) |
it is properly constituted under the laws of the country or state of incorporation and has full power and authority to enter into this Agreement; |
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(b) |
it has obtained all necessary corporate approvals to enter into this Agreement; |
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(d) |
it is entitled to grant the rights and licenses to the other Party as set out in this Agreement; |
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(e) |
it shall obtain and maintain throughout the term of this Agreement all permits, licenses, registration and other forms of government authorization and approval as required by applicable laws in order for each Party to execute and deliver this Agreement and to perform their obligations in accordance with all applicable laws; and |
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(f) |
it shall comply with all laws, legal and regulatory requirements applicable to performance of its obligations under this Agreement; and |
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(g) |
in complying with its obligations under this Agreement, neither it, its Affiliates, nor any of its or its Affiliates employees, agents, or permitted Subcontractors, will make payments or provide anything of value to any government official or to any other person knowing that it will be paid or offered to such official or any other person knowing that it will be paid or offered to such official (i) for the purpose of influencing the official to act or make a decision on Customer’s behalf which is in violation of the official’s lawful duty, or (ii) to induce the official to influence any government act or decision in Customer’s favor. |
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(a) |
It will perform the Packaging Services in compliance with the Packaging Process and cGMP; |
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(b) |
Supplier Provided Bulk Products will comply with cGMP, the relevant Bulk Specifications and Supplier ANDAs; and |
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(c) |
It has full rights and access to the Intellectual Property rights relating to the Supplier Provided Bulk Products, and the supply of the Supplier Provided Bulk Products in line with this Agreement will not infringe any Intellectual Property rights of third parties. |
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(a) |
Customer Provided Bulk Products will comply with the relevant Bulk Specifications; and |
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(b) |
It has full rights and access to the Intellectual Property rights relating to the Final Products and the Customer Provided Bulk Products, and the provision of the Packaging Services in line with the Packaging Process and the terms of this Agreement – including, for the avoidance of doubt, (i) the import, export, storage and use of Customer Provided Bulk Products in/to the country where the Packaging Services are performed as well as the storage of the Final Products and (ii) the use of the artworks and advertising/packaging provided or approved by Customer for the Packaging Services and Delivery of the Final Product – will not infringe Intellectual Property Rights of third parties. |
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8.5 |
Notification of Defective Final Products. Customer shall notify Supplier of any claims of Defective Final Product in writing within the following timelines: |
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(a) |
For Apparent Defects, Customer shall have the right to place a Defective Final Product claim under this Clause 8.5 provided that such claim is made in writing to Supplier within [***] following receipt of the Defective Final Product by Customer at Customer’s warehouse; and |
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(b) |
For Latent Defects of which it becomes aware during the shelf life of a Final Product, Customer shall have the right to place a Defective Final Product claim under this Clause 8.5 provided that such claim is made in writing to Supplier within [***] following discovery of the Defect. |
In the event that Customer does not notify Supplier of any claims of Defective Final Product in writing within the above timelines, such Final Products shall be deemed free from Defects and accepted by Customer.
8.6 |
Handling of Defective Final Products. In the event that any Final Product is Defective and Customer notifies Supplier of any Defect in accordance with this Clause 8, Supplier shall, subject to Clause 8.7 and following good faith discussions between the Parties in order to arrive at a mutually agreed upon outcome, either (i) replace any Defective Final Product with conforming Final Product; (ii) if Supplier and Customer have agreed upon a process for reworking or reprocessing Final Product, rework or reprocess any Defective Final Product in accordance with such approved process; or (iii) refund to Customer the Price paid for, as applicable, such Delivery or partial Delivery if already paid by Customer or issue a credit note where not already paid. Further, Supplier shall instruct Customer without undue delay to either send back to Supplier or dispose of any Defective Final Products, at Supplier’s cost and discretion. Customer’s rights under this Clause 8.6 shall be Customer’s sole remedies with regard to the supply of Defective Final Products by Supplier. |
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(a) |
either Party may request in writing for such unresolved dispute to be determined by an independent first-class laboratory; |
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(b) |
upon receipt of such request, the Parties shall jointly appoint an independent first-class laboratory within [***]. The independent laboratory shall be bound to the Parties by obligations of confidentiality no less exacting than those applying between the Parties pursuant to this Agreement; |
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(c) |
the independent laboratory shall within [***] following its appointment determine the root cause of the non-conformity or Defect and its findings shall be conclusive and binding upon the Parties; and |
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(d) |
all fees and expenses of the independent laboratory shall be borne solely by the unsuccessful Party. |
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(a) |
Any breach by the Indemnifying Party of its representations and warranties given under this Agreement; |
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(b) |
Negligence, fraud or willful misconduct in performing the Indemnifying Party’s obligations under this Agreement; |
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(c) |
Any patent infringement or infringement of any other Intellectual Property caused by the Indemnifying Party in performing the Indemnifying Party’s obligations under this Agreement; and/or |
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(d) |
Any breach of statutory duty or any criminal act by the Indemnifying Party, |
except (in the case of (a) through (d)) to the extent that such losses etc. arise from the breach, negligence or willful misconduct of any Indemnified Party.
10.1 |
Quality Agreement. The Parties shall enter into a separate Quality Agreement relating to the Parties’ quality responsibilities substantially in accordance with [***], before Supplier commences the Supplier Bulk Supply and/or Packaging Services for Customer for commercial production. |
10.4 |
Customer Cost. [***]. |
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10.5 |
Product Recalls. The rules on recalls of Finished Products are set out in the Quality Agreement. |
11.1 |
General. Customer is responsible for fulfilling its pharmacovigilance obligations arising from its Marketing Authorizations in the Territory. No exchange of pharmacovigilance information applies. |
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(a) |
is or becomes part of the public domain without a violation of this Agreement; |
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(b) |
was already in its possession at the time of receipt from the disclosing Party, as shown by documentary evidence; or |
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(c) |
after the date of this Agreement is received from a third party whose direct or indirect source is not the disclosing Party. |
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13.1 |
Term. This Agreement shall come into effect on the Effective Date and shall continue in force for a fixed term of five (5) years following Launch, unless terminated earlier in accordance with its terms (the “Initial Term”). This Initial Term shall automatically be extended by a subsequent three (3) year period (the “Extended Term”), unless terminated by either Party upon its sole discretion by written notice, such notice to be given no later than twenty four (24) months prior to expiry of the Initial Term. Any further extensions require a mutual written agreement between the Parties. The Initial Term, the Extended Term and any further extensions together constitute the “Term”. |
14.1 |
Governing Law. This Agreement and the legal relations between the Parties in connection herewith shall be governed by, and construed in accordance with, the laws of the England and Wales, excluding the provisions of the United Nations Convention on Contracts for the International Sale of Goods and any conflict of law provisions that would require application of another choice of law. |
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such subcontract or supply relationship. If within [***] following receipt of a notice referred to in the second sentence of this Clause 15.2, Customer notifies Supplier in writing that such proposed subcontract by Supplier could impact the Registration for the Final Product, [***]. |
15.3 |
Annexes. All Annexes (and any amendments to such Annexes) and their enclosures form an integral part of this Agreement and are incorporated herein by reference. |
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force and effect and shall be enforceable, and the invalid one shall be replaced by a regulation which meets the original economic intent of the invalid provision as far as legally possible. |
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the Parties have signed this Agreement on the dates set out below:
For and on behalf of Sandoz GmbH
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For and on behalf of Phathom Pharmaceuticals, Inc |
Signature: /s/ Xxxxxxx
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Signature: /s/ Xxxxxx Xxxxxx |
Name: Xxxxxxx Xxxxxx
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Name: Xxxxxx Xxxxxx
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Title: President, Global B2B |
Title: Chief Executive Officer |
Date: December 30, 2020 |
Date: December 30, 2020 |
For and on behalf of Sandoz GmbH
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For and on behalf of Phathom Pharmaceuticals, Inc |
Signature: /s/ Xxxx Xxxxxxxxxx
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Signature: /s/ Xxxx Xxxxxxx
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Name: Xxxx Xxxxxxxxxx
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Name: Xxxx Xxxxxxx
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Title: Director Business Partnering Global B2B |
Title: Chief Operating Officer |
Date: December 30, 2020 |
Date: December 30, 2020 |
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Annex 1
DEFINITIONS AND INTERPRETATION
The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:
“Additional Product” means a pharmaceutical product in final packaged form (including with package leaflet and instructions for use) containing [***].
“Affiliate” means any corporation or other business entity which, directly or indirectly, is controlled by, controls, or is under common control with Customer or Supplier as the case may be. For such purposes, “Control” shall mean the direct or indirect ownership of at least fifty percent (50%) of the voting interest in such corporation or other entity or the power in fact to control the management directions of such entity.
“Agreement” means this Supply and Packaging Services Agreement.
“Annex” means an annex to this Agreement.
“Apparent Defect” means any Defect which is visible or easily detectible through routine incoming quality control measures.
“Background Intellectual Property” has the meaning in Clause 7.1.
“Batch” means a defined quantity of Final Products, Bulk Products, Customer Supplied Materials or any other materials used for the Packaging Services, processed in one process or series of processes, so that it could be expected to be homogeneous.
“Bulk Products” has the meaning in Clause 1.3.
“cGMP” means current Good Manufacturing Practices promulgated by the Regulatory Authorities in the jurisdictions included in Applicable Laws. In the United States, this includes 21 C.F.R. Parts 210 and 211, as amended; and in Europe, this includes 2003/94/EEC Directive (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended, if and as implemented in the relevant constituent country.
“Claims” has the meaning in Clause 9.1.
“Clause” means a clause of this Agreement.
“Confidential Information” has the meaning in Clause 12.1.
“Confirmed Delivery Date” has the meaning in Clause 5.3.
“Confirmed Order” has the meaning in Clause 5.3.
“Confirmed Order Quantities” has the meaning in Clause 5.3.
“Customer” has the meaning attributed to it in the preamble of this Agreement.
“Customer Provided Bulk Products” has the meaning in Clause 1.3.
“Defective Final Product” refers to Final Products that do not conform to the Packaging Process and/or that contains Supplier Provided Bulk Product that does not conform to the Supplier Bulk Specifications. “Defect” shall be interpreted accordingly.
“Deliver” or “Delivery” means the delivery of the Final Product by Supplier pursuant to Clause 5.10.
“Effective Date” has the meaning attributed to it in the preamble of this Agreement.
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“Equipment” means any equipment and machinery required in the provision of the Packaging Services hereunder.
“Exclusive Purchase Period” has the meaning in Clause 3.7.
“Extended Term” has the meaning in Clause 13.1.
“Facility” means Supplier’s manufacturing facility located at [***] and as may be amended from time to time.
“FDA” means the U.S. Food and Drug Administration.
“Final Product” means the following pharmaceutical products in final packaged form (including with package leaflet and instructions for use) which is the end product of the Packaging Services as defined in Annex 3, and includes the Additional Product, if any.
“Force Majeure” has the meaning in Clause 15.6.
“Forecast” has the meaning in Clause 5.1.
[***]
“Further Implementation Services” has the meaning in Clause 2.3.
“Indemnified Party” has the meaning in Clause 9.1.
“Indemnifying Party” has the meaning in Clause 9.1.
“Initial Term” has the meaning in Clause 13.1.
“Intellectual Property” means patents (whether patentable or not), trade secrets, know-how, confidential or proprietary information, technical data, trademarks, service marks, design rights, copyright or any other intellectual property right which may subsist anywhere in the world, whether capable of grant, registration or not.
“Latent Defect” means any Defect other than Apparent Defects.
“Launch” means the first commercial sale of the Final Product in the Territory to a third party.
“Launch Year” means each twelve (12) month period commencing upon Launch of the Final Product. The first 12-month period following Launch shall be referred to as “Launch Year 1”, the second 12-month period following Launch shall be referred to as “Launch Year 2”, etc.
“LoI” means the letter of intent entered into between the Parties on letter of intent on August 27. 2020, a copy of which is attached hereto as Annex 2.
“Manufacturing Phase” has the meaning in Clause 1.6.
“Marketing Authorization” means, in respect of a Final Product, such marketing authorization, approval, license, registration or other authorizations issued by a Regulatory Authority in connection with the placing of that Final Product on the market in the Territory.
“Minimum Capacity” has the meaning in Clause 5.5.
“Minimum Order Quantities” has the meaning in Clause 5.6.
“Minimum Purchase Quantities” has the meaning in Clause 5.7.
“Order” has the meaning in Clause 5.2.
“Order Lead Time” has the meaning in Clause 5.2.
“Package” or “Packaging” means (as applicable) any and all activities relating to the Packaging Services, including the packaging, preparation, testing, handling, storage and supply of Final Products in accordance with the terms of this Agreement.
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“Packaging Material(s)” means, collectively, any primary and/or secondary packaging materials (including any leaflets and instructions for use) as well as any other components necessary to provide the Packaging Services according to the terms of this Agreement.
“Packaging Process” means the process to be followed when providing the Packaging Services, as described in detail in Annex 3 (Packaging Process).
“Packaging Services” means any and all services in relation to the Packaging of the Bulk Products to be carried out by or on behalf of Supplier in line with the Packaging Process, including without limitation the receipt of materials, primary and/or secondary packaging (as the case may be), processing, testing, quality control, releasing, storing, sample retention, serialization and packaging for shipment.
“Parties” means the Supplier together with Customer, each individually may be referred to as a “Party”.
“Quality Agreement” means the quality agreement to be entered into by the Parties (or their Affiliates) in line with Clause 10.1.
“Quality Assurance” or “QA” means the sum total of the quality assurance arrangements made with the purpose of ensuring that the Final Product meets the Specifications and is of the quality required for its intended use and shall specifically include all terms and activities as set forth in the applicable version of the Quality Agreement.
“Registration” means any and all governmental or Regulatory Authority approvals necessary or required for the processing, Packaging, importation, marketing, distribution and sale of the Final Product as labeled, packaged and presented for sale to the pharmaceutical trade, and the term “Registration” shall also apply to any renewals of such approvals and to any other steps required to maintain such approvals.
“Regulatory Authority” means any international, national or other governmental, regulatory or administrative authority or other body competent to grant, maintain and extend approvals (including pricing), registrations or other consents for the processing, Packaging, importation, marketing, distribution or sale of pharmaceutical products, including without limitation the Final Products.
“Representatives” has the meaning in Clause 12.1.
“Requested Delivery Date” has the meaning in Clause 5.2.
“Requested Order Quantities” has the meaning in Clause 5.2.
“Set-up Phase” has the meaning in Clause 1.6.
“Set-up Activities” has the meaning in Clause 2.1.
“Subcontractor” has the meaning in Clause 15.2.
“Supplier” has the meaning attributed to it in the preamble of this Agreement.
“Supplier ANDAs” means [***], certain abbreviated new drug applications filed by Supplier with the FDA for certain finished products containing the Supplier Provided Bulk Products.
“Supplier Bulk Specifications has the meaning in Clause 3.2.
“Supplier Bulk Supply” has the meaning in Clause 1.2.
“Supplier Provided Bulk Products” means Supplier’s proprietary pharmaceutical products specified Clause1.3 to be manufactured by Supplier or its Affiliates and to be provided by Supplier in addition to the Packaging Services and to be included in the Final Products.
“Term” has the meaning in Clause 13.1.
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“Territory” means the United States of America.
“VAT” means within the European Union such taxation as may be levied in accordance with (but subject to derogation from) Council Directive 2006/112/EC and outside the European Union any taxation levied by reference to added value or sales.
In this Agreement unless otherwise specified:
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(a) |
the division of this Agreement into Clauses, sub-clauses and Annexes and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement; |
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(b) |
the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement; |
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(c) |
a statute or statutory instrument or any of their provisions is to be construed as a reference to that statute or statutory instrument or such provision as the same may have been or may from time to time hereafter be amended or re-enacted; |
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(d) |
all references to the singular shall include the plural and vice versa; |
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(e) |
the term “including” shall mean “including without limitation”; and |
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(f) |
any reference in this Agreement to a “day” or “week” shall be references to a calendar day or week. Where express reference is made to “business day(s)” any such reference shall mean a day (with the exception of Saturday and Sunday) on which banks are open in Austria and New York, New York. |
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LETTER OF INTENT
[***]
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FURTHER IMPLEMENTATION SERVICES
[***]
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BULK SPECIFICATIONS
[***]
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Annex 5
Packaging Process
Finished Products - Specifications:
[***]
Process Flow Chart:
[***]
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PRICES
Product Price and MOQ
[***]
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