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Contract Terms Pharmaceutical Industry

Goodwin

Harrow Enters Agreement to Commercialize Samsung Bioepis’s Ophthalmology Biosimilars Following Biogen’s Exit

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On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna)...more

Goodwin

Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar

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On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

A&O Shearman

Creative deal structures help life sciences innovators ride out the macro storm

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Globally, market volatility has eroded confidence and subdued M&A activity. A “wait and see” approach is the prevailing sentiment for many market participants; it is difficult to convince boards to advance deals while...more

Goodwin

Delaware Court Awards More Than $180 Million for Breach of Commercially Reasonable Efforts Obligation in Drug Development...

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On June 11, 2025, the Delaware Court of Chancery found Alexion Pharmaceuticals liable for more than $180 million in damages to former stockholders of Syntimmune, Inc., following the Court’s September 2024 ruling that Alexion...more

Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

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On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

Goodwin

FDA Approves BLA for Novavax’s COVID-19 Vaccine

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On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

Goodwin

Five Trends Reshaping Pharmaceutical Manufacturing Partnerships

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How CDMOs are reshaping pharmaceutical partnerships through friendshoring, risk-sharing economics, and specialized development capabilities. The pharmaceutical manufacturing landscape is undergoing a profound shift, with...more

Fenwick & West LLP

Navigating and Litigating 'Commercially Reasonable Efforts' Provisions: Considerations and Strategies for Tech & Life Sciences...

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Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

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Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

McDermott Will & Schulte

This Week in 340B: February 25 – March 3, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Hogan Lovells

New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 21.02.2025

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Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more

Goodwin

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

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On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Wiley Rein LLP

Contracting With PBMs: Critical High-Value Issues to Consider

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Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more

Cadwalader, Wickersham & Taft LLP

Delaware Court of Chancery Clarifies “Commercially Reasonable Efforts” in Earn-Out Provisions

On April 30, 2024, in Himawan, et al. v. Cephalon, Inc., et al., the Delaware Court of Chancery held that the defendant acquiror complied with its contractual obligations to use commercially reasonable efforts to achieve...more

BCLP

Differentiated general terms and conditions of sale

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Distribution: In two rulings issued on 28 September 2022, the French Supreme Court clarified the conditions under which suppliers can be held liable for failure to comply with their duty to communicate - Article L.441-1...more

TransPerfect Legal

What’s Trending: Milestone Disputes in Life Sciences Litigation

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Earlier this month, the ACC hosted an illuminating panel presentation on Life Sciences Litigation: A Look at Milestone Disputes & Recent Trends. Panelists included Lauri Mims and Jennifer Huber, both Partners at Keker Van...more

Herbert Smith Freehills Kramer

Sustained or Transitory? Delaware Court of Chancery Finds No MAE Absent Proof of Durationally Significant Effect on Business

Prior to the Delaware Court of Chancery’s opinion in Akorn, Inc. v. Fresenius Kabi AG, C.A. No. 2018-0300-JTL, 2018 WL 4719347 (Del. Ch. Oct. 1, 2018), aff’d 198 A.3d 724 (Del. 2018), no Delaware court had found the existence...more

Proskauer - The Patent Playbook

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Skadden, Arps, Slate, Meagher & Flom LLP

Diligence Clauses and the Management of Uncertainty in Life Sciences Agreements

In times of uncertainty and disruption, setting expectations for performance with business partners and contractual counterparties can be more complicated than ever. Companies that develop drugs, biologics and medical devices...more

Farrell Fritz, P.C.

Commercial Division Denies Pfizer’s Motion To Dismiss, Holds Allergan’s Claims for Defense Costs Are Ripe

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It’s back to business as usual for Commercial Division Justice Andrew Borrok, who recently issued a slew of decisions contributing to New York’s robust Commercial Division jurisprudence....more

Cadwalader, Wickersham & Taft LLP

The Delaware Court of Chancery Rejects Termination of Merger Agreement Based on Material Adverse Effect

In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more

Seyfarth Shaw LLP

Close Was Not Close Enough: First Circuit Denies Executive’s Implied Covenant Claim For Unpaid Equity Compensation Related To A...

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Seyfarth Synopsis: On November 27, 2019, the United States Court of Appeals for the First Circuit held that, under Massachusetts law, a terminated employee asserting a claim for being deprived of lost compensation in breach...more

BCLP

Securities and Corporate Governance Update – October 2019

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This newsletter discusses noteworthy updates, key regulatory decisions and upcoming compliance reminders. In this edition, we review: ...SEC Changes Approach to Shareholder Proposal No-Action Requests ...SEC Issues...more

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