QUALITY AGREEMENT OF MANUFACTURE AND SUPPLY 

QUALITY AGREEMENT OF MANUFACTURE AND SUPPLY 

This Manufacture and Supply Agreement is made and executed on this ___ day of _________ 202__ (“Effective Date”) By and Between

First Part , a company incorporated under the Companies Act, 1956 having its registered office at __________________________________________ and its corporate office at ___________________________________________ or meaning thereof be deemed to mean and include its successors and permitted assigns) of the One Part;

And

Second Party, (hereinafter referred to as “Manufacturer” which expression shall unless repugnant to the context or meaning thereof be deemed to mean and include its successors and permitted assigns) of the Other Part;

First Party and Manufacturer may individually be referred to as “Party” and collectively as “Parties”.

WHEREAS:

1. First Party is a leading pharmaceutical company and engaged in the research and development, manufacture, marketing and distribution of wide range of cosmetics, nutraceuticals and pharmaceutical products.
2. Manufacturer is engaged in the manufacture, sale and distribution of pharmaceutical products.
3. Manufacturer represents to First Party that Manufacturer has with its own skill, research, process and method, developed formulations of the Products (as defined below) and further it has the requisite infrastructure and resources to manufacture the same at its Factory (as defined below). ­
4. First Party and Manufacturer are desirous of entering into this Agreement whereby First Party will market the Products in the Territory under First Party’s Trade Mark / generic name; and Manufacturer has agreed to (i) manufacture the Products; and (ii) sell the Products to First Party on the terms and conditions as stated herein.

NOW THIS QUALITY AGREEMENT WITNESSETH AND IT IS HEREBY AGREED BY AND BETWEEN THE PARTIES HERETO AS UNDER:

1. DEFINITIONS AND INTERPRETATION:

• DEFINITION:

Unless otherwise specified the following words used with initial capitals in this Agreement shall have the meaning assigned to it herein below: –

• “Affiliate” shall mean a person or entity which Controls, or is Controlled by or is under common Control with a Party to this Agreement, where “Control” or “Controlled by” means direct or indirect (a) ownership of at least 50% of the outstanding voting securities of a corporation or a comparable equity interest in any other type of entity or (b) power to direct or cause the direction of the management and policies of such person whether through the ownership of voting securities, by agreement or otherwise or (c) the power to elect or remove more than one-half of the directors, partners or other individuals exercising similar authority with respect to such person;
• “Agreement” shall mean this Manufacture and Supply Agreement and includes all schedules, annexures and any amendments thereto;
• “cGMP(s)” shall mean the Current Good Manufacturing Practices established under (i) the Laws of the country where the Factory is located; and/or (ii) the Laws of the Territory, which govern the manufacturing activities of the Product, and any amendments thereto;
• “Change of Control” shall mean the direct or indirect acquisition of either the majority of the voting rights of a Party, or of all, or substantially all, of the assets, of a Party by another entity in a single transaction or a series of transactions;
• “Confidential Information” shall mean oral or written proprietary information in tangible or non-tangible form relating to the Products and/or the business of the Parties, which shall be inclusive of but not limited to (i) know how, Product, technical information; (ii) manufacturing processes, technology, methods, analytical skills; (iii) drug master file, dossiers; (iv) research and development data, plans/results; (v) data, observations, findings of pre-clinical/clinical trials, studies and experimental work; (vi) sales and marketing plans and strategies; (vii) procurement, purchase and manufacturing requirements/information; (viii) cost and pricing information; (ix) details of customers, vendors, third parties; (x) future projections, business plans, forecasts and financial information; (xii) patents, trademarks, copyrights, service marks, designs, trade secrets and information; (xiii) any other projects; and (xiv) all materials prepared on the basis of any of the foregoing, whether or not the foregoing information is patented, tested, reduced to practice in whatever form and using whichever media, whether marked as confidential or not;
• “Delivery Date” shall mean the date specified in the Purchase Order for the delivery of the Product at the Delivery Location;
• “Delivery Location” shall mean Ex-Works (Factory) or as stated in the Purchase Order or as per the instructions from First Party.
• “Factory” shall mean the manufacturing facility owned by Manufacturer situated at Plot No.__________________________________________ and duly approved by the Regulatory Authority to manufacture and supply the Products;
• “Intellectual Property Rights” shall mean all rights and interest in the intellectual property, trade secrets, know-how, technology and information, whether or not protected by patents, arising by common law or by statute in relation to the Products;
• “Laws” shall mean any law, statute, rule, regulation, guideline (including current Good Manufacturing Practices and Good Distribution Practices) ordinances or other pronouncements of any governmental or regulatory authority having the effect of law in the Territory where the Products are marketed and/or the country where the Factory is located;
• “Product” shall mean the finished formulation of a drug or cosmetic or a nutraceutical affixed with the Trademark, manufactured at the Factory as per the Laws and Specifications, as listed in Annexure A hereto;
• “Purchase Order” shall mean an order for the Products placed by First Party in accordance with this Agreement;
• “Purchase Price” shall mean the price for the Product as stated in the Purchase Order or as mutually agreed between the Parties as per the terms herein;
• “Regulatory Approval” shall mean the approval/s, permissions issued to First Party by the Regulatory Authority for the manufacture, marketing, sale and distribution of the Product in the Territory;
• “Regulatory Authority” shall mean any applicable Central, State, or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the manufacture, distribution and sale of the Products, including, as the case may be such as the Food and Drug Administration, Food Safety and Standard Authority of India, Ministry of Health (MOH) or the respective regulatory authority in the Territory;
• “Shelf Life” shall mean the period between the manufacturing date and expiry date as stated on the Product pack during which the Products can stay on the shelf without degrading to unacceptable levels and considered unsuitable for sale or consumption;
• “Specifications” shall mean the quality specifications as approved by the Regulatory Authority and shall be inclusive of but not limited to specifications for i) raw material and packaging material; ii) Products; iii) manufacturing formula; iv) manufacturing process flow chart; v) label/carton/foil artwork; vi) Material Safety Data Sheet (MSDS) as set out in the Technical Agreement;
• “Technical Agreement or (“TA”) shall mean an agreement as executed or would be executed between the Parties dealing with detailed checklist of the activities / responsibilities including but not limited to the cGMP requirements, material management and storage, production/quality control, manufacturing and packaging of Products, transportation, testing and release of the Products and same shall form an integral part of this Agreement as Annexure B. In the event of any inconsistency between the TA and Agreement, the provisions of this TA shall prevail to the extent that the inconsistency relates to technical issues otherwise the provisions of this Agreement shall prevail;
• “Territory” shall mean the countries agreed between the Parties and as stated in Annexure A;
• “Term” shall have the meaning set out in Clause 19.1 of this Agreement;
• “Trademark” shall mean all trademarks, trade names, logos, designs, symbols, emblems, insignia, fascia, slogans, information, drawings, plans and other materials provided by First Party in connection with the Products and stated in Annexure A.

• INTERPRETATION:

In this Agreement (except where the context otherwise requires):

• clause headings do not affect the interpretation;
• references to any legislation shall include any statutory or other re-enactment or modification thereof (whether before or after the date of this Agreement);
• where the context requires, words denoting the singular include the plural and vice versa and words denoting any gender include all genders;
• recitals shall form an integral part of the Agreement;
• in the case of any conflict or ambiguity between any provision contained in the body of this Agreement and any provision contained in any Annexure to it and/or any Purchase Order, the provisions of this Agreement shall prevail; and
• reference to a person includes companies or other bodies corporate as well as individuals, partnerships and all types of firms, associations and unincorporated bodies.

1. PURPOSE AND SCOPE
   • First Party shall on non-exclusive basis purchase the Products from Manufacturer, and Manufacturer shall manufacture and sell the Product as per the Purchase Order.
   • It is agreed between the Parties that, for the purposes of this Agreement, First Party may act either on its own or through its Affiliates.
   • First Party has represented that First Party is purchasing the Product from Manufacturer for sale by itself or its Affiliates or through its customers in the Territory.
   • The Parties shall, within a period of one (1) month from the Effective Date execute the Technical Agreement.
2. REGULATORY SUBMISSIONS:
   • Upon request of First Party, Manufacturer shall unconditionally provide all assistance and support required by First Party for: (a) preparation of regulatory submissions, including but not limited to, answering the queries raised by Regulatory Authorities for obtaining Regulatory Approval; (b) providing any information or documentation required by the Regulatory Authority for obtaining Regulatory Approval of the Product in the name of First Party; (c) providing Product samples with or without First Party’s brand name as per the requirement, for regulatory filings; (d) any other assistance required by First Party in this regard; (e) making its employees, consultants and other staff available upon reasonable notice during normal business hours to attend meetings with Regulatory Authorities concerning the Product or any inspections of manufacturing sites, where relevant; and (f) disclosing and making available to First Party and/or the Regulatory Authority, in such form as may be required by any applicable Regulatory Authority, all manufacturing and quality control data, CMC data and other information related to the Product and Finished Product and the manufacturing process as is reasonably necessary to prepare, file, obtain and maintain any regulatory approval.
   • Manufacturer shall nominate a single point of contact for all regulatory enquires.
   • First Party will provide a list of requirements to Manufacturer in relation to the Product. Manufacturer will provide all relevant documents in an electronic format to First Party in line with an agreed timetable between both the Parties. Manufacturer will ensure that all queries received from Regulatory Authorities are responded to within the timeframe defined by the Regulatory Authorities.
   • Post Approval: Following the Regulatory Approval of the Product, if any new requirements are mandated by the Regulatory Authorities then Manufacturer will provide necessary support to First Party to meet the new regulatory standards. Manufacturer will support First Party with additional documents, when necessary.
3. PURCHASE ORDERS
   • First Party shall place Purchase Order thirty (30) days prior to the Delivery Date. The Purchase Order shall contain amongst other details the quantity, the Purchase Price, the Delivery Date, Delivery Location etc. Failure by Manufacturer to confirm such Purchase Orders within two (2) working days shall be termed as deemed acceptance.
   • Manufacturer shall supply the Product as stated in the Purchase Order.
   • First Party may at any time prior to despatch of the Products amend or cancel a Purchase Order by written notice to Manufacturer. If First Party amends or cancels a Purchase Order, its liability to Manufacturer shall be limited to the payment of all irreversible justified evidenced costs reasonably incurred by Manufacturer in fulfilling the Purchase Order up to the date of receipt of the notice of amendment or cancellation. However, First Party shall not be liable to make any payments where such amendment or cancellation is due to Manufacturer’s failure to comply with its obligations under this Agreement.
   • If the Products are not delivered on the Delivery Date then, without prejudice to any other rights which it may have, First Party reserves the right to:
     • a discount @20% on the Purchase Price on the subsequent Purchase Order;
     • cancel the Purchase Order/s in whole or in part; and
     • claim damages for any costs, losses, expenses or penalties incurred by First Party including but not limited any forward claims which First Party may receive (for failure to supply the Product by First Party to its customers in the Territory), which are in any way attributable to Manufacturer‘s failure to deliver the Product on the Delivery Date.

• RAW & PACKING MATERIALS
  • Manufacturer shall at its own risk and expense procure the raw and packing materials for manufacturing the Product and shall be responsible for the quality and suitability of the raw and packing materials.
  • Manufacturer shall ensure that the raw and packing materials are stored under recommended storage conditions and specifications.
  • Manufacturer shall not, without the prior written consent of First Party, alter or make any addition to the labelling or packaging of the Products displaying the Trademark, and shall not alter, deface or remove in any manner any reference to the Trademark, any reference to First Party or any other name attached or affixed to the Products or their packaging or labelling.
• MANUFACTURING OF THE PRODUCTS
  • Manufacturer shall:
    • ensure that the Products are free from manufacturing defects and liens;
    • manufacture store, handle, inspect, test, package, label and deliver the Product in strict conformity with this Agreement;
    • ensure that the Products are properly packed and secured in such manner as to enable them to reach their destination in good condition and remain so throughout the Shelf Life of the Products;
    • ensure that the Products shall be labelled in accordance with the art work as approved by First Party and in accordance to the rules and regulations of the Territory;
    • be responsible for any Product quality complaints and/ or adverse events attributable to the quality of the Products unless it is proved that the Product has not been stored as per the recommended storage condition mentioned in the label;
    • not sell, supply, deliver or part with the possession of the Products or any part thereof to any entity other than First Party unless duly authorized by First Party in writing;
    • maintain adequate samples from batches of the Products to undertake stability studies as may be required under the applicable Laws;
    • pack the Products in such form and in such manner as specified by First Party and affix on the package, the Trademark, label or outer covering or wrapper containing the legal and other declarations and/or such other information as is required under any Laws for the time being in force.
  • Capacity Allocation. Manufacturer shall devote and maintain adequate manufacturing capacity capable of manufacturing and supplying the requirements of Product to First Party in accordance with the provisions of this Agreement. If, at any time during the Term, for any reason Manufacturer is unable to meet First Party’s requirements of the Product, Manufacturer shall allocate capacity at the Factory to each of its customers/partners (including First Party) on a pro-rata basis.
• OBLIGATIONS OF MANUFACTURER
  • Manufacturer undertakes and agrees to:
    • bear and pay all taxes, cess, duties, assessments etc. including any penalties which are in Law to be borne by the owner and/or occupier of the Factory and/or manufacturing of the Products;
    • maintain quality control testing documentation for the raw & packaging materials and the Products of each batch as per the Laws;
    • be solely responsible for all employee related issues including but not limited to compensation, expenses etc. and First Party shall in no way be liable or responsible for the same;
    • manufacture and furnish First Party physician samples as per its requirements on mutually agreed prices;
    • store the Products under suitable conditions to ensure their fitness and merchantability at all times, whilst in its possession or under its control;
    • inform First Party ninety (90) days in advance of any Change of Control;
    • supply the Products at the Delivery Location with a left over Shelf-Life of 95%;
    • at its own cost, obtain insurance for the raw material, packaging material, the Products in process and the Products while the same are in its possession;
    • observe and abide by all the Laws as may be applicable in the discharge of its obligations under this Agreement;
    • be responsible for Product quality, efficacy and safety till the Shelf Life as prescribed by the Laws.
• RIGHTS & OBLIGATIONS OF FIRST PARTY
  • First Party agrees with Manufacturer to:
    • apply for, obtain and maintain valid Trade Marks registrations;
    • provide Manufacturer with Specifications;
    • place timely Purchase Order;
    • ensure proper storage of the Products as specified on the label after accepting delivery of the Products;
    • make payment to Manufacturer within ninety (90) days of the receipt of the Products and the undisputed invoice;
    • advise on the maximum retail price and any other label declaration, if any to be affixed on the Product pack.
• TITLE

The risk, title and interest in the Products shall be transferred from Manufacturer to First Party on the delivery of the Products at the Delivery Location.

• RECALL

In the event of a voluntary and/or mandatory recall, for any reason whatsoever, First Party shall forthwith administer the recall and Manufacturer shall cooperate and assist First Party. In the event of a recall due to quality or any reasons attributable to Manufacturer (including its manufacturer), all such cost shall be borne by Manufacturer. If First Party bears the expenses of the recall attributable to Manufacturer, then the same shall be reimbursed and/or adjusted against the Purchase Price.

• INSPECTION
  • Manufacturer shall with forty-eight (48) hours prior intimation allow First Party’s team to visit and audit the Factory. Manufacturer shall extend their fullest co-operation in meeting the requirements of First Party’s team.
  • First Party can audit the Factory any time, with prior intimation (unless otherwise directed by any Regulatory Authority), if deemed necessary as part of investigation in case of Product quality complaint or adverse event reported by consumer, government agencies, health care professionals and pharmacist or any other source.
  • Manufacturer shall, on request, allow First Party to inspect and take copies of (or extracts from) all relevant records and materials relating to the manufacture and supply of the Products as may be reasonably required in order to verify such matters.
• TESTING & DEFECTIVE PRODUCTS
  • Manufacturer shall provide First Party along with each consignment of the Products, the Certificate of Analysis (“COA”) for each batch of Products supplied to
  • First Party shall have a right to analyze or have each consignment of the Products received from the Manufacturer analyzed internally or by a third party. If the result of such analysis differs from the Specifications, then First Party shall inform and provide a copy of the analysis report. On receipt of the analysis report, Manufacturer shall within fifteen (15) working days communicate its acceptance/rejection of the same.
  • In the event of any difference between Manufacturer and First Party over the results of analysis report, the Parties shall get a sample from the consignment in question analyzed by a mutually acceptable independent laboratory and the results submitted by such laboratory shall be binding on the Parties.
  • If the Products are found to be non-conforming to the Specifications, then without limiting any other right or remedy that First Party may have, First Party shall at its option be entitled to any of the following remedies:
    • if in the opinion of First Party, the defect is capable of being remedied:
      • First Party shall send the Products to Manufacturer, at the cost and expenses of Manufacturer to get the defect remedied within thirty (30) working days of being requested to do so; and
      • First Party shall be eligible for a discount @20% on the Purchase Price on the subsequent Purchase Order.
    • If the Products are not capable of being remedied:
      • First Party or Manufacturer shall destroy the Products and the cost of such destruction shall be borne by Manufacturer; and
      • Manufacturer shall replace the rejected quantity of the Products free of charge within a period of thirty (30) days; and
      • First Party shall be eligible for a discount @20% on the Purchase Price on the subsequent Purchase Order.

The aforesaid shall be without prejudice to First Party’s right to claim damages for any costs, losses, expenses or penalties incurred by First Party including but not limited any forward claims which First Party may receive (for failure to supply the Product by First Party to its customers in the Territory), which are in any way attributable to Manufacturer‘s delivery of Product that are not in conformity with the terms of the Specifications.

• First Party shall at all times be granted access by Manufacturer to all documentation and control samples related to the batch of the Product.
• IMPROVEMENTS AND CHANGES TO THE PRODUCT
  • Any change, improvement or modification to the agreed Specifications, source of API, process and equipment related to the Product (whether prior to or subsequent to commercialization), shall be only upon the prior written approval of First Party. If any such improvement or modification is arising due to change in Laws, then the Parties shall discuss, mutually agree and record such change, improvement or modifications in writing.
  • If the Parties mutually agree to amend the Specifications or make any improvements or modifications to the Product and Manufacturer is unable to supply such Products for any reason whatsoever, then First Party shall be free to terminate this Agreement without cost or expenses.
• CONSIDERATION AND PAYMENT
  • First Party shall not be liable to pay any extra charges over and above the Purchase Price.
  • Manufacturer shall be entitled to invoice for each Purchase Order on or at any time after delivery of the Products at the Delivery Location. Each invoice shall quote the relevant Purchase Order number/s and such other information as First Party may require.
  • First Party shall make payment of the Purchase Price within ninety (90) days from the date of the receipt of the Products and the undisputed invoice. Invoice shall be raised by Manufacturer in Indian National Rupees (INR).
  • Taxes:
    • All payments payable hereunder shall be inclusive of goods and service tax (“GST”) and subject to deduction of taxes as statutorily required.
    • Manufacturer shall provide Manufacturer’s correct PAN and a self-declaration that Manufacturer is not a specified person, as provided in Sec 206AB or Sec 206CCA of the Income Tax Act 1961, as the case may be, for the purpose of deduction/collection of TDS/TCS at a higher rate.
    • Manufacturer shall issue a valid tax invoice / debit or credit note in the format prescribed under the relevant Good and Service Tax (GST) Act and rules framed thereunder (“GST Law”) including (e-invoicing requirement). If the services provided by Manufacturer are taxable under GST, Manufacturer shall ensure that the contents prescribed by the GST Law like GST number along with HSN code for services and QR code/IRN number (if applicable) are reflected on the face of the invoice. Further, the tax invoice / debit or credit note shall be uploaded on the GSTN portal within the prescribed timelines. Manufacturer shall incorporate the transaction with First Party under this Agreement in the periodical statutory returns filed by it within the prescribed time as required under the relevant and applicable GST Law and shall ensure that all taxes due as per the said return has been duly remitted in the manner prescribed under applicable law. Non – compliant invoices will be rejected with reasons and Manufacturer shall be required to send the revised invoice / debit or credit note. This is mandatory to ensure compliance with GST. If GST is exempted, necessary certificates and declaration is to be provided to First Party;
    • Any mismatches reported by GSTN portal if due to error by Manufacturer shall be reconciled and resolved by Manufacturer within the prescribed time. In all such cases where First Party is not able to avail input tax credit of GST amount paid or denied to First Party on account of mismatches on GSTN portal, non-payment of GST to government or non-filing of GST returns or non-uploading of invoice within due timelines or uploading invoice with incorrect GSTIN of First Party or other reasons attributable to any failure on Manufacturer part including (e-invoicing requirement), then Manufacturer agrees that First Party shall have the right to set-off any such amounts (along with interest and penalty payable to government authorities) from any amounts that is already due or will become due and payable to Manufacturer under this Agreement or any other agreement. Further, First Party also reserves the right to recover the amount from Manufacturer for which the input tax credit of GST could not be availed and any interest and penalty so charged by government on First Party for such default of Manufacturer by raising a debit note, Manufacturer will be responsible to make payment against such debit note within 7 days from date of issuance of debit note.
    • Manufacturer shall further indemnify, hold harmless and defend at its costs, expense First Party, its directors, officers and employees, its affiliates in relation to:
      • any claims from applicable tax authorities including interest/penalty or any amounts levied upon/paid by First Party due to the default, error or non-compliance of Manufacturer;
      • any loss/denial of input tax credit to First Party due to non-compliance of GST regulation by Manufacturer or due to late submission of invoices by Manufacturer;
      • any interest and/or penalty levied/paid by First Party to tax authorities in relation to loss/denial of input tax credit to First Party as mentioned in above point; and/or
      • non-compliance of obligations set out hereinabove in respect to GST Law and under other applicable laws
    • First Party shall have no obligation to pay the Purchase Price for any consignment of the Products received which are not as per Specifications and are subject to a claim of non-compliance or defect.
    • Manufacturer shall use all reasonable endeavors throughout the Term of this Agreement to reduce its manufacturing, supply and other costs for the Products, including implementing cost savings initiatives and seeking more competitive supplies of raw materials and equipment. The net benefit of cost reductions shall be applied to reduce the Purchase Price with immediate effect.
    • Manufacturer shall provide all such evidence as First Party may reasonably request in order to verify:
      • invoices submitted by Manufacturer;
      • any increase proposed in the Purchase Price; and
      • cost reductions achieved by Manufacturer (including the dates on which cost reductions were achieved).
    • During the Term of this Agreement, in the event of a change in the prices of raw material, packaging material or API, the Parties will consider a revision in the Purchase Price of the Product/(s). The Parties will discuss the price revision and shall mutually agree upon the revised Purchase Price, in writing.
    • During the Term of this Agreement, the Parties agree that the Product is likely to face competition in the Territory which could impact the pricing and commercial potential of the Product. Manufacturer agrees to lower the Purchase Price of the Product and benchmark it based on the lowest price of similar product(s) of competitive supplier/s, First Party shall provide the names of the competitive supplier/s on whose prices the Purchase Price will be benchmarked.
    • If the Parties are unable to arrive at a mutually acceptable Purchase Price then First Party shall have the right to terminate the Agreement and / or the Agreement in respect of such Product/(s).
• REPRESENTATIONS AND WARRANTIES
  • Manufacturer hereby represents and warrants to First Party that on the Effective Date and during the term of the Agreement that:
    • it has the capability to manufacture and supply to First Party the quantities of Products ordered, on the Delivery Date;
    • the Factory is routinely maintained and operated in accordance with cGMP to enable an audit and approval from the Regulatory Authority, as per the regulatory compliance, health and safety requirements of the country of manufacture;
    • it shall hold and maintain all required licenses/approvals/authorization and shall ensure the validity and effectiveness of all approvals, licenses, permits, permissions, sanctions applicable for manufacture of the Products in compliance with the laws of (a) the country of manufacture; and (b) the Territory;
    • the Products supplied by Manufacturer will be as per the approved Specifications;
    • the Product shall be of merchantable quality, fit for the purpose and free from defects;
    • it has developed its own technical know-how to manufacture the Products and does not violate Intellectual Property Rights of any third party in the country of manufacture and the Territory;
    • the Products have been packaged, labelled and stored in compliance with the approved Specifications;
    • the Product has not been adulterated or otherwise defective at the time of delivery to First Party;
    • the Products at the time delivery to First Party is free and clear of all security interests, liens and other encumbrances of any kind or character;
    • it shall follow all laws, rules and regulations as may be applicable to it in performance of its obligations under this Agreement including the anti-bribery and anti-corruption laws, and will not take any action that will cause First Party or its affiliates to be in violation of any such laws rules and regulations.

 CONFIDENTIALTY

Each Party agrees that the Confidential Information of the other Party shall be confidential information. The receiving Party agrees to hold Confidential Information in strict confidence and disclose it only to those who need to know the same and who are under an obligation to maintain the same confidential. The foregoing obligations shall not extend to any confidential information which (a) is or becomes generally available to the public otherwise than as a result of a disclosure by receiving Party; or (b) which can be shown to have been known prior to its receipt from disclosing Party; or (c) is subsequently disclosed to receiving Party without being made subject to an obligation of confidence by a third party; or (d) is required to be disclosed by law of regulation. Each Party agrees that it will not disclose the terms of this Agreement to any third party without the written consent of the other Party. These obligations of confidentiality and nondisclosure shall remain in effect for a period of two (2) years after the expiry or termination of the Agreement.

• PERMITTED USE OF TRADEMARK
  • First Party hereby grants to Manufacturer a non-exclusive, non-transferable, non-assignable and non-sub-licensable right to affix the Trade Marks on the label and/or the packages and/or the Products in accordance with the directions and specifications given by First Party.
  • Manufacturer shall not use, nor shall be deemed to have the right to use the Trade Marks in connection with or in relation to any other product, other than the Products hereunder manufactured or dealt with by Manufacturer.
  • Nothing herein contained shall give or be deemed to give or shall be intended to give Manufacturer any right, title, interest or claim in or to the Trade Marks.
  • Manufacturer shall during the continuance of the Agreement use its best endeavors to discover any infringement or passing off or suspected infringement or imitation of the said Trade Marks coming to its knowledge and shall communicate the same to First Party and assist First Party in any action to be taken in such circumstances.
• TERM & TERMINATION
  • This Agreement shall remain in force for a period of three (3) years from the Effective Date (“Term”) unless terminated earlier as stated below. This Agreement shall be renewed with the mutual written consent of the Parties on such terms and conditions as would be agreed upon.
  • First Party may terminate this Agreement or with regard to a Product or some of the Products/(s) in all or any of the countries in the Territory, without assigning any reason whatsoever by giving fifteen (15) days prior written notice to Manufacturer.
  • Notwithstanding anything contained herein, in the event of material breach by either Party hereto of any of its obligations hereunder, the non-breaching Party may serve written notice on the other specifying the ground of its complaint and requiring the Party in default to remedy the breach. If the Party in default shall not remedy the breach within ninety (90) days after receipt of such notice, the non-defaulting Party may terminate this Agreement forthwith by issuing notice in writing and/or initiate legal proceedings. Such termination shall be without prejudice to all or any claims that the Parties may have against each other.
  • Either Party may terminate this entire Agreement by issuance of a termination letter sixty (60) days in advance and may initiate legal action, if the other Party:
    • ceases to do business, becomes unable to pay its debts when they fall due, becomes or is deemed insolvent, has a receiver, manager, administrator, administrative receiver or similar officer appointed in respect of the whole or any part of its assets or business, makes any composition or arrangement with its creditors, takes or suffers any similar action in consequence of debt, an order or resolution is made for its dissolution or liquidation (other than for the purpose of solvent amalgamation or reconstruction) or enters into liquidation whether compulsorily or voluntarily;
    • any Laws or decree that renders the performance by a Party of its obligations hereunder onerous or otherwise inexpedient.
  • First Party shall be entitled to terminate the Agreement forthwith by issuing a letter of termination:
    • if there is delay or failure on the part of Manufacturer to supply the Products at least two (2) times in a period of twelve (12) months;
    • if the Products delivered by Manufacturer do not meet the Specifications at least two (2) times in a period of twelve (12) months;
    • in the event the Regulatory Authority raise any objection on the sale of the Product(s);
    • if the manufacturing license and / or any other licence of Manufacturer is terminated;
    • if the Product is recalled by First Party and / or by the Regulatory Authority and / or due to reasons attributable to Manufacturer;
    • if the Parties are unable to arrive at a revised Purchase Price;
    • unable to amend the Specifications or make any improvements or modifications to the Product.
  • Change of Control: If there is a change in the ownership and/or control of Manufacturer, Manufacturer shall inform First Party in advance and secure in writing its approval of such change. If First Party provides its written approval to such change of control, this Agreement shall not terminate and instead automatically stand assigned to the succeeding party who shall be bound by the rights and obligations of Manufacturer under this Agreement.
  • It is clarified that, if the Agreement encompasses more than one Product; such termination may be on a Product by Product basis and the termination shall apply only in respect of such Products and the Agreement shall continue with respect of other Products.
  • This Agreement may be terminated at any time by mutual written consent of both the Parties.
  • In the event on any dispute or difference arising with regard to the subject matter of this Agreement is sub-judice, then neither Party can terminate this Agreement until the dispute/difference is resolved, except agreed in writing.
• EFFECTS OF TERMINATION
  • First Party shall pay all undisputed unpaid invoices within a period of ninety (90) days from the date of receipt of the Products and the invoice.
  • Upon the termination of this Agreement for any reason whatsoever, Manufacturer shall:
    • forthwith discontinue manufacture of the Products with First Party’s Trademark;
    • not make any use of and / or promptly return to First Party, and/or at First Party’s option destroy in the presence of First Party’s representative, all and any Confidential Information or other information in its possession or control relating to First Party or this Agreement and all Intellectual Property Rights including artwork or other materials relating to the labelling and packaging of the Products;
    • not use the Trade Mark(s) and/or other Intellectual Property Rights of First Party.
  • In the event of expiry or termination of this Agreement, both the Parties shall be bound to honour their obligations accrued prior to the effective date of expiry or termination. For this purpose, relevant provisions of this Agreement relating to manufacture, supply and payments shall be deemed to be in force until performance of respective obligations by the Parties hereto. Further, termination of this Agreement however caused shall be without prejudice to any rights or liabilities accrued at the date of termination.
• INDEMNITY
  • Each Party (“Indemnifying Party”) hereby indemnifies and agrees to keep the other Party (“Indemnified Party”) at all times harmless and indemnified from and against all costs and consequences arising as a result of any action, suit, proceedings, or claims made by any person, party, customer or authorities against Indemnified Party in respect of the following:
    • any breach by Indemnifying Party of the terms of this Agreement;
    • any negligent act or omission on the part of Indemnifying Party.
  • Manufacturer hereby indemnifies and agrees to keep First Party, its employees and representatives at all times harmless and indemnified from and against all costs and consequences arising as a result of any action, suit, damages, expenses, recoveries, proceedings or claims made by any person, party, customer or authorities against First Party including reasonable legal expenses and costs including attorneys’ fees, in respect of any infringement or alleged infringement of any Intellectual Property Rights of Manufacturer, manufacturing defect, use, manufacture, packing and supply of the Product including but not limited to any product liability claims from Regulatory Authority or  as asserted by end users of the Product(s).
  • First Party hereby indemnifies and agrees to keep Manufacturer at all times harmless and indemnified from and against any claim made against Manufacturer in respect of an infringement or alleged infringement of any Intellectual Property Rights of First Party caused by marketing, sale and distribution of the Products by First Party under the said Trademark.
• GOVERNING LAW AND JURISDICTION

This Agreement shall be governed by and construed in accordance with the laws of India and the courts at Mumbai shall have exclusive jurisdiction.

• NOTICES
  • Any notice or other communication given under or in connection with this Agreement shall be in writing and shall be delivered personally or sent by registered post or courier, to the Party due to receive the notice at its /their addresses as below or such other address as either Party may specify by notice in writing to the other.

To MANUFACTURER:

To First Party:

First Party ______________________________________________________________________

Attention: Legal Department

• In the absence of evidence of earlier receipt, any notice or other communications shall be deemed to have been duly given:
  • if delivered personally, when left at the address referred to in this Clause; and
  • if sent by registered post or courier, ten days after posting it.
• GENERAL
  • Assignment: Manufacturer shall neither assign its obligations to any entity nor sub-contract its obligations under this Agreement, without the prior written consent of First Party.
  • Waiver: The failure of either Party to enforce or to exercise any terms and conditions of this Agreement does not constitute a waiver of such terms and conditions and shall in no way affect that Party’s right later to enforce or to exercise it.
  • Severability: If any provision of this Agreement is held to be invalid or unenforceable for any reason, it shall be adjusted rather than voided, if possible, in order to achieve the intent of the Parties to the fullest extent possible. In any event, all other provisions of this Agreement shall be deemed valid and enforceable to the fullest extent possible.
  • Entire Agreement: This Agreement constitutes the entire agreement and understanding of the Parties in relation to its subject matter and supersedes any and all other previous agreements, arrangements and/or understandings (whether written or oral) between the Parties in relation to its subject matter hereunder. In the case of any conflict or ambiguity between any provision contained in the body of this Agreement and any provision contained in any Annexure to it and/or any Purchase Order, emails, invoices and / or other documents the provisions of this Agreement shall prevail.
  • Amendments: This Agreement including the annexures shall not be modified, except when confirmed in writing by the duly authorized representatives of the Parties hereto. All amendments to or deletions from this Agreement shall be made in writing and be signed by all Parties hereto.
  • Force Majeure:
    • Neither Party shall be deemed to be in breach of this Agreement or otherwise be liable to the other by reason of any delay in performance or non-performance of any of its obligations hereunder to the extent that such delay or non-performance is due to any Force Majeure event (provided that the Party claiming Force Majeure has used all reasonable endeavours to mitigate the event of Force Majeure and carries out its obligations under this Agreement as far as is practicable) of which it has notified that other Party and the time for performance of that obligation shall be extended accordingly if the act agreed upon has not become impossible to perform.
    • If the Force Majeure event in question prevails for a continuous period in excess of one month then the Parties shall enter into bonafide discussions with a view to alleviate its effects or to agree upon such alternative arrangements as may be fair and reasonable. If the Parties are unable to arrive at a mutual solution, then the Party which has not suffered the Force Majeure, will have the right to terminate the Agreement by issuing a termination letter forthwith.
    • For the purposes of this Agreement Force Majeure shall mean acts of god.
  • Survival: Any terms of this Agreement which are either expressed so as to survive (or are capable of surviving) expiry, or termination of this Agreement or from their nature or context it is contemplated that they are to survive expiry, or termination, shall remain in full force and effect notwithstanding expiry or termination.
  • Principal to Principal Relationship: Nothing in this Agreement and no action taken by the Parties pursuant to this Agreement shall constitute or be deemed to First Party and Manufacturer as a partner, joint venture, association or other co-operative entity of the other and shall not appoint either Party as agent of the other for any purposes whatsoever either in or outside the Territory. Neither shall have the authority or power to bind the other Party’s name or create any liability against the other Party in any way or for any purpose. It is hereby specifically stated that First Party’s role under this Agreement is that of independent contractor and no other.
  • Pharmacovigilance – SDEA: The pharmacovigilance obligations of the Parties shall be as laid down in Annexure C hereto.
  • Manufacturer agrees and undertakes to comply with First Party’s Supplier Code of Conduct .
  • Manufacturer (i) will not, directly or indirectly, in violation of any applicable law, including, without limitation, the U.S. Foreign Corrupt Practices Act or the UK Bribery Act 2010 or similar laws or any First Party Ethics, Anti-bribery and Anti-corruption policies as First Party may update them from time to time; (1) make any contribution, gift, bribe, rebate, payoff, influence payment, kickback, or other payment to any person or entity, private or public, regardless of form, whether in money, property, or services: (i) to obtain favourable treatment in securing business, (ii) to pay for favourable treatment for any business secured, or (iii) to obtain special concessions or for special concessions already obtained, for or in respect of First Party or any of its affiliates; or (2) establish or maintain any fund or asset for that purpose that is not recorded in the books and records of First Party; and (ii) will act so as to comply with all applicable laws, including, without limitation, the U.S. Foreign Corrupt Practices Act or the UK Bribery Act, 2010 or any similar laws, ordinances, regulations, rights of concession, licenses, know-how, or other proprietary rights, of others.
  • This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Agreement transmitted by email in “portable document format” (“.pdf”), or by any other electronic means shall have the same effect as physical delivery of the paper document bearing original signature. 

IN WITNESS WHEREOF the Parties hereto have executed these presents the day month and year first hereinabove written

For First Party by its duly authorized representative as s/he so declares	For Second Party Pharmaceuticals Pvt. Ltd. by its duly authorized representative as s/he so declares
Name:	Name:
Designation:	Designation:

 

GENERIC NAME	COMPOSITION	ACTIVE INGREDIENT	TRADEMARK	TERRITORY

ANNEXURE B

TECHNICAL AGREEMENT

(Page intentionally left blank – to be annexed separately)

 ANNEXURE C

PHARMACOVIGILANCE – SDEA

This PV clause supplements the terms of the Commercial Agreement(s) as described for the Product and Territory.

• First Party as the “Marketer and distributor”
• Second Party  as the “Manufacturer and MAH”

Pharmacovigilance responsibilities

Second Party shall be responsible for fulfilling all Pharmacovigilance obligations that includes ICSR, PSUR, Signal detection, RMP and RSI updates as required by local legislation.

First Party during the execution of its duties shall provide Second Party with any and all appropriate information necessary for Second Party to record, process and report ICSR(s) as outlined in applicable laws and regulations.  At Second Party’s request, First Party agrees to cooperate and assist in obtaining follow-up or supporting information on reported information.

In the event that First Party or its subcontractors authorized under this Agreement receives any reports on ICSR relating to a patient taking the Quality Complaints Product or any Medical Information Enquiry or Product (PQC), First Party shall notify Second Party within 4 calendar days or 2 business days (from day zero i.e. date of first receipt by original recipient) (whichever is earlier) of learning of the ICSR. First Party shall report the event directly to Second Party’s pharmacovigilance department at the contact details mentioned in the section Key Pharmacovigilance Contacts.

Second Party will provide the First Party an acknowledgement of receipt for individual cases received from the First Party through email delivery confirmation within one (1) business day of receipt which will serve as an evidence of reconciliation of exchange of Safety information. The relevant reference number assigned to the case will be shared within 7 calendar days from the date of receipt for First Party’s records. If the acknowledgment for reference number is not received, the First Party should send a reminder to Second Party until receipt is confirmed.

In case of no exchange of information between parties, an e-mail confirmation for No exchange of Safety information within stipulated time period will be sent every 6 months by Second Party.

Training

First Party and Second Party are responsible for ensuring that personnel involved in pharmacovigilance within their respective companies and approved subcontractors (where applicable) are properly trained and qualified and have been informed of their obligations under this Agreement. This training should be fully documented.

Key Pharmacovigilance Contacts 

Contact details	First Party	Second Party
Territory
Reference No.
Correspondence Address
Local PV Responsible Person
AE reports, Medical Information Enquiries and Product Quality Complaints email ID
PVC Related Queries
Safety related email ID
Reconciliation/ Acknowledgement related email ID

QUALITY MANAGEMENT SYSTEM IN PHARMA